protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT02753842 | 8.1 | Adverse Event Definitions and Reporting Requirements | 8.1 Adverse Event Definitions and Reporting Requirements | [] |
NCT02753842 | 8.1.1 | Adverse Events Definitions | 8.1.1 Adverse Events Definitions | [] |
NCT02753842 | 8.1.1.1 | Adverse Events | 8.1.1.1 Adverse Events An AE is defined as any unfavorable or unintended sign (including laboratory findings), symptom or disease that occurs to a subject while enrolled in a clinical trial that could be associated with the use of the study intervention. Medical conditions that exist at study enrollment are not conside... | [] |
NCT02753842 | 8.1.1.2 | Serious Adverse Events | 8.1.1.2 Serious Adverse Events We do not anticipate serious adverse events occurring in this study due to the nature of the study intervention. | [] |
NCT02753842 | 8.1.2 | Adverse Events Reporting | 8.1.2 Adverse Events Reporting Study participants will receive instructions to report any untoward medical occurrences that could be associated with the study intervention to study staff, except for possible life-threatening events, where they will seek immediate emergency care. If the participant receives care from a ... | [] |
NCT02753842 | 9 | STATISTICAL CONSIDERATIONS | 9. STATISTICAL CONSIDERATIONS | [] |
NCT02753842 | 9.0 | Study Aims | 9.0 Study Aims The primary aims are: - 1. To compare fitted condoms with standard condoms regarding levels of reported pleasure as determined by rating per condom use event. - 2. To compare fitted condoms with standard condoms regarding preference as determined by ranking of the two conditions at the study conclusion. ... | [
"Secondary aims:",
"Other areas of research interest:"
] |
NCT02753842 | 9.1 | Study Hypotheses | 9.1 Study Hypotheses Hypotheses of the primary aims are: - 1. Fitted condoms will have higher pleasure ratings than standard condoms. - 2. More participants will prefer fitted condoms than standard condoms. - 3. All condom conditions will have clinical failure point estimates less than a cut-point level of acceptable c... | [] |
NCT02753842 | 9.2 | Study Rationale | 9.2 Study Rationale Rationale for the primary aims are: - 1. There is biological plausibility and published data indicating that condoms fitted to penile dimensions could improve perceptions of pleasure. - 2. There is biological plausibility and published data indicating that condoms fitted to penile dimensions could i... | [] |
NCT02753842 | 9.3 | Sample Size | 9.3 Sample Size We will seek to have at least 404 participants complete the trial. To accomplish this goal, we will target enrollment of 504 participants, estimating 20% loss to follow-up. If the loss to follow-up is greater than 20%, we may seek additional recruitment. The study will have a MSM arm and a MSW arm, with... | [] |
NCT02753842 | 9.4 | Data Analysis | 9.4 Data Analysis Table 2. Outcome measures used to assess each study aim | | Aim | Outcome measure | |---|------------------------------------|------------------------------------------------------| | 1 | To compare fitted condoms with | Pleasure-scale score (response item mean) for fitted | | | standard condoms regar... | [] |
NCT02753842 | 9.5 | Study blinding | 9.5 Study blinding The study statistician and the principal investigator, who are responsible for analyses and reporting results to FDA, will be blinded until after the initial analysis of study results has been lodged with FDA. Participants will also be blinded in order to minimize bias. The different condom types wer... | [] |
NCT02753842 | 10 | HUMAN SUBJECTS CONSIDERATIONS | 10. HUMAN SUBJECTS CONSIDERATIONS | [] |
NCT02753842 | 10.0 | Ethical Review | 10.0 Ethical Review Prior to study initiation, approval of the protocol, study documents, and informed consent process will be provided by the Emory University IRB. | [] |
NCT02753842 | 10.1 | Informed Consent | 10.1 Informed Consent The principles of Informed Consent, according to FDA Regulations and International Conference on Harmonization (ICH) guidelines on Good Clinical Practice (GCP), will be followed. The principal investigator will submit a copy of the proposed ICFs, together with the study protocol, to the Emory Univ... | [] |
NCT02753842 | 10.2 | Risks to participants | 10.2 Risks to participants Following are anticipated risks to participation, and procedures to reduce risk: • Persons may learn they have HIV or possibly an STI, and this may be upsetting. To minimize this risk, we will have counselors and other study staff who have been trained in HIV counseling and testing conducting... | [] |
NCT02753842 | 10.3 | Anticipated benefits to research participants | 10.3 Anticipated benefits to research participants We do not anticipate benefits to individuals, except for learning one's HIV status and receiving appropriate counseling, and being linked to treatment and care as needed. The broader community may benefit in the future, as this study is designed to allow scientists to ... | [] |
NCT02753842 | 10.4 | Incentives | 10.4 Incentives Participants will be reimbursed for their time and effort in this study. Participants who attend a baseline enrollment visit will be compensated \$50 for the visit regardless of their eligibility or future study participation. Participants will be reimbursed \$35-\$50 for each follow-up visit they atten... | [] |
NCT02753842 | 10.5 | Notifying Participants of Study Findings | 10.5 Notifying Participants of Study Findings We will inform participants of the results of their biomedical tests, consisting of a rapid HIV test at their baseline visit and, as needed, results of tests performed to detect acute HIV infection. | [] |
NCT02753842 | 10.6 | Participant Privacy and Confidentiality | 10.6 Participant Privacy and Confidentiality Our efforts to protect privacy and confidentiality are evident in several areas: study procedures, training, and data management practices. Study Procedures: We will collect multiple means of contact for participants during the initial study visit. For each means of contact,... | [] |
NCT02753842 | 10.7 | Communicable Disease Reporting Requirements | 10.7 Communicable Disease Reporting Requirements Study staff will comply with all applicable local requirements to report communicable diseases identified among study participants to local health authorities. Participants will be made aware of all reporting requirements during the study informed consent process. | [] |
NCT02753842 | 10.8 | Study Discontinuation | 10.8 Study Discontinuation This study may be discontinued at any time by the Emory University IRB as part of its duties to ensure that research subjects are protected. | [] |
NCT02753842 | 11 | LABORATORY SPECIMENS AND BIOHAZARD CONTAINMENT | 11. LABORATORY SPECIMENS AND BIOHAZARD CONTAINMENT | [] |
NCT02753842 | 11.0 | HIV Testing | 11.0 HIV Testing At enrollment events, an FDA-approved HIV rapid test, the INSTI HIV-1 antibody test, (PMA number: BP090032/0) will be used for HIV screening. Participants with a preliminary positive test result will receive standard counseling messages per CDC recommendations. All preliminary positive results will be ... | [] |
NCT02753842 | 11.1 | Acute HIV Testing | 11.1 Acute HIV Testing At enrollment and follow-up visits, we will assess plasma viral load for participants who present with symptoms that may be indicative of acute HIV infection. We will use the Abbott RealTime HIV-1 Assay, an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay, for viral load me... | [] |
NCT02753842 | 11.2 | Laboratory Specimens | 11.2 Laboratory Specimens Participants with preliminary positive HIV rapid test results will have blood drawn to be sent to the study laboratory for confirmation. Participants who are symptomatic for acute HIV infection will have blood drawn to be sent to the study laboratory for viral load testing. The study staff wil... | [] |
NCT02753842 | 11.2.1 | Study laboratories will include: | 11.2.1 Study laboratories will include: 1. Quest Diagnostics 2801 N Decatur Rd Suite 185 Decatur, Georgia 30033-5924 2. Kraft Labs 101 Woodruff Circle, Room 7007 Atlanta, Georgia 30322 | [] |
NCT02753842 | 11.3 | Biohazard Containment | 11.3 Biohazard Containment As the transmission of HIV and other blood-borne pathogens can occur through contact with contaminated needles, blood, and blood products, appropriate blood and secretion precautions will be employed by all study staff in the drawing of blood, as currently recommended by Occupational Safety a... | [] |
NCT02753842 | 12 | ADMINISTRATIVE PROCEDURES | 12. ADMINISTRATIVE PROCEDURES | [] |
NCT02753842 | 12.0 | Data Collection, Entry and Management | 12.0 Data Collection, Entry and Management Study data collection will be predominantly electronic, and based on the Dacima CDMS platform. Dacima CDMS is a secure data collection tool that allows users to create online data collection forms, instruments, and databases, and can be implemented to allow compliance with FDA... | [] |
NCT02753842 | 12.1 | Quality Assurance | 12.1 Quality Assurance Monitoring visits will be made periodically by the principal investigator during the study to ensure that all aspects of the current, approved protocol/amendment(s) are followed. The study may also be subject to a quality assurance audit by the sponsor or its designees, as well as inspection by a... | [] |
NCT02753842 | 12.2 | Regulatory Requirements | 12.2 Regulatory Requirements The study will be conducted in accordance with Title 21 CFR Part 11 and GCP guidelines. The study will obtain Emory University IRB approval for the protocol and Informed Consent forms prior to initiating the study. All changes to the protocol will be submitted to the Emory University IRB fo... | [] |
NCT02753842 | 12.3 | Institutional Review Board | 12.3 Institutional Review Board Prior to initiating the study, the principal investigator will submit the following to the Emory University IRB: the verbal and electronic consent for screening, informed consent, this protocol, and materials used to recruit subjects for this clinical trial. No subjects will be recruited... | [] |
NCT02753842 | 13 | REFERENCES | 13. REFERENCES - 1. Centers for Disease Control and Prevention. Incidence, Prevalence, and Cost of Sexually Transmitted Infections in the United States. 2013; http://www.cdc.gov/std/stats/stiestimates-fact-sheet-feb-2013.pdf. Accessed June 22, 2015. - 2. Centers for Disease Control and Prevention. HIV in the United Sta... | [] |
NCT02791230 | A | P H A S E 3 M U L TI C E N T E R, O P E N L A B E L S T U D Y T O E V A L U A T E T H E S A F E T Y O F D AI L Y O R A L D O SI N G O F T A F A MI DI S M E G L U MI N E ( P F- 0 6 2 9 1 8 2 6 8 3) 2 0 M G O R 8 0 M G [ O R T A F A MI DI S ( P F - 0 6 2 9 1 8 2 6- 00) 6 1 M G] I N S U B J E C T S DI A G N O S E D W I T ... | A P H A S E 3 M U L TI C E N T E R, O P E N L A B E L S T U D Y T O E V A L U A T E T H E S A F E T Y O F D AI L Y O R A L D O SI N G O F T A F A MI DI S M E G L U MI N E ( P F- 0 6 2 9 1 8 2 6 8 3) 2 0 M G O R 8 0 M G [ O R T A F A MI DI S ( P F - 0 6 2 9 1 8 2 6- 00) 6 1 M G] I N S U B J E C T S DI A G N O S E D W I ... | [] |
NCT02791230 | D | oc u me nt Hist or y | D oc u me nt Hist or y | D oc ume nt | Versi o n D ate | S umm ar y of C h a n ges a n d R ati o n ale | |---------------------------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02791230 | P | R O T O C O L S U M M A R Y | P R O T O C O L S U M M A R Y
B ac k gr o u n d a n d R ati o n ale: Pfizer is de vel o pi n g tafa mi dis, a n oral s mall m olec ule, f or t he treat me nt of tra nst h y reti n a m yl oi d diseases. Tra nst h yreti n car di o my o pat h y ( T T R C M or A T T R C M) occ urs w he n tra nst h yreti n ( T T R) a myl o... | [
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NCT02791230 | S | a m ple Size R ati o n ale | S a m ple Size R ati o n ale T here is n o f or mal sa m ple size calc ulati o n f or t his pr ot oc ol. S u bjects w h o meet e nr oll me nt criteria are eli gi ble; U p t o 2 0 0 0 s u bjects are e x pecte d t o e nr oll i n St u d y B 3 4 6 1 0 4 5.
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NCT02791230 | S | C H E D U L E O F A C TI VI TI E S | S C H E D U L E O F A C TI VI TI E S T he sc he d ule of acti vities ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures. Refer t o t he [S T U D Y P R O C E D](#page-41-0) U R E S a n d [A S S E S S M E N T S](#page-52-1) secti o ns of t he pr ot oc ol f or detaile d i nf or mati o n o n ... | [
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NCT02791230 | T | his is a list of a b bre vi ati o ns t h at m a y be use d i n t he pr ot oc ol. | T his is a list of a b bre vi ati o ns t h at m a y be use d i n t he pr ot oc ol. | A b bre vi ati o n | Term | |--------------------|----------------------------------------------------------------| | A E | a d verse e ve nt | | A L | ala ni ne a mi n otra nsferase | | A S T | as partate a mi n otra nsferase | | B B ... | [
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NCT02792231 | A | randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis Document type: Amended Protocol Version EUDRACT number: 2015-005419-33 Version number: v02 Clean Clinical trial phase: III Release date: 06-Au... | [
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NCT02799602 | 1 | Title page | 1. Title page A randomized, double–blind, placebo–controlled Phase III study of darolutamide (ODM–201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone–sensitive prostate cancer Darolutamide in addition to standard androgen deprivation therapy and doc... | [
"Confidential",
"Signature of the sponsor's medically responsible person",
"Signature of principal investigator"
] |
NCT02799602 | 2 | Synopsis | 2. Synopsis | Title | A randomized, double–blind, placebo–controlled Phase III study ofdarolutamide (ODM–201) versus placebo in addition to standardandrogen deprivation therapy and docetaxel in patients withmetastatic hormone–sensitive prostate cancer | | | |----------------------|--------------------------------------... | [
"Exclusion criteria",
"Screening period:",
"Treatment period:",
"Active Follow–up period:",
"Active Follow–up visits",
"Long–term (survival) Follow–up period:",
"Survival sweep:",
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"List of abbreviations",
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NCT02799602 | 3 | Introduction | 3. Introduction | [] |
NCT02799602 | 3.1 | Background | 3.1 Background Prostate cancer is the second most common cancer and the fifth leading cause of cancer death among men worldwide [\(1\)](#page-92-16). It is the most common non–cutaneous cancer and the second leading cause of cancer–related deaths in men in Europe [\(2](#page-92-15)) and the United States ([3\)](#page-9... | [] |
NCT02799602 | 3.2 | Overview of darolutamide (BAY 1841788) | 3.2 Overview of darolutamide (BAY 1841788) | [] |
NCT02799602 | 3.2.1 | Pharmacology | 3.2.1 Pharmacology Darolutamide is a novel non–steroidal androgen receptor (AR) inhibitor which binds with high selectivity and binding affinity (9 nM) to AR when compared to known second-generation anti–androgens. Darolutamide is a 1:1 mixture of 2 pharmacologically active diastereomers: (S,R)-darolutamide and (S,S)-d... | [] |
NCT02799602 | 3.2.2 | Nonclinical pharmacokinetics and metabolism | 3.2.2 Nonclinical pharmacokinetics and metabolism Darolutamide is rapidly absorbed in mice and rats from preclinical formulations. Dog studies show that fasted and fed states differ in darolutamide absorption with fed states showing higher total exposure than fasted states. Upon repeated dosing, no accumulation was obs... | [] |
NCT02799602 | 3.2.3 | Safety pharmacology and toxicology | 3.2.3 Safety pharmacology and toxicology The repeat–dose toxicity studies with darolutamide have been conducted up to 26 weeks in the rat and up to 39 weeks in the dog. Darolutamide has been well tolerated up to the highest dose levels in both species. The no observable adverse effect level was >2 x 500 mg/kg/day in th... | [] |
NCT02799602 | 3.2.4 | Drug–drug interactions | 3.2.4 Drug–drug interactions The information on darolutamide drug-drug interactions is provided in the latest available version of the Investigator's Brochure (IB) for darolutamide. Docetaxel will be administered after randomization according to standard treatment practice. Docetaxel is mainly metabolized by CYP3A4. Th... | [] |
NCT02799602 | 3.2.5 | Clinical studies with darolutamide | 3.2.5 Clinical studies with darolutamide As of 02 OCT 2015, 173 subjects with mCRPC have been treated with darolutamide. Darolutamide has been studied in 7 clinical trials: a first–in–man study with cohort expansion (Study 17829 / 3104001, ARADES), a long–term safety extension study for the first–in–man study (Study 18... | [] |
NCT02799602 | 3.3 | Rationale of the study | 3.3 Rationale of the study Management of advanced prostate cancer has evolved considerably in recent years and new therapeutic agents with diverse mechanisms of action have dramatically changed the paradigm of treatment. However, the vast majority of advances have been made in subjects with metastatic castration–resist... | [] |
NCT02799602 | 3.4 | Benefit–risk assessment | 3.4 Benefit–risk assessment Darolutamide treatment has been well tolerated in clinical studies in mCRPC subjects. There is no important risk identified. Fall and non–pathological fractures are currently considered important potential risks. No dose–limiting toxicities were observed in the phase I dose escalation. The A... | [] |
NCT02799602 | 4 | Study objectives | 4. Study objectives The primary objective of this study is: To demonstrate the superiority in OS of darolutamide in addition to standard ADT and docetaxel over placebo in addition to standard ADT and docetaxel The secondary objectives of this study are to evaluate: - Time to castration–resistant prostate cancer - Time ... | [] |
NCT02799602 | 5 | Study design | 5. Study design
Design overview This is an international, randomized, double–blind, placebo–controlled phase III study of darolutamide in subjects with mHSPC. The estimated sample size is approximately 1,300 subjects (see Section [10.4\)](#page-82-1). The start of the study period is defined by signing of the informed... | [
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NCT02799602 | 6 | Study population | 6. Study population | [] |
NCT02799602 | 6.1 | Inclusion criteria | 6.1 Inclusion criteria Subjects must meet the following criteria at the time of Screening: - 1. Written informed consent. - 2. Males ≥18 years of age. - 3. Histologically or cytologically confirmed adenocarcinoma of prostate. - 4. Metastatic disease documented either by a positive bone scan, or for soft tissue or visce... | [] |
NCT02799602 | 6.2 | Exclusion criteria | 6.2 Exclusion criteria Subjects who meet any of the following criteria at the time of Screening will be excluded: - 1. Prior treatment with: - LHRH agonist/antagonists started more than 12 weeks before randomization - Second–generation AR inhibitors such as enzalutamide, ARN–509, darolutamide, other investigational AR ... | [] |
NCT02799602 | 6.3 | Justification of selection criteria | 6.3 Justification of selection criteria The inclusion/exclusion criteria used in this study, including concomitant conditions and medications as outlined above and in Section [8.1](#page-45-1) are based upon knowledge of the known toxicity profile of the agent under investigation and the understanding of the concomitan... | [] |
NCT02799602 | 6.4 | Withdrawal of subjects from study | 6.4 Withdrawal of subjects from study | [] |
NCT02799602 | 6.4.1 | Withdrawal | 6.4.1 Withdrawal
Withdrawal criteria
General procedures In all cases, the reason for withdrawal must be recorded in the case report form (CRF) and in the subject's medical records. The subject may object to the generation and processing of post–withdrawal data as specified in Section [13.4](#page-89-1). Details for t... | [
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NCT02799602 | 6.4.2 | Replacement | 6.4.2 Replacement A subject withdrawn from the treatment with study drug will not be replaced. | [] |
NCT02799602 | 6.5 | Subject identification | 6.5 Subject identification The subject number is a 9–digit number consisting of: Digits 1 to 2 = Country code Digits 3 to 5 = Center number within the country (Digits 1 to 5 = Trial unit) Digits 6 to 9 = Current subject number within the center | [] |
NCT02799602 | 7 | Treatment(s) | 7. Treatment(s) | [] |
NCT02799602 | 7.1 | Treatments to be administered | 7.1 Treatments to be administered
Study drugs The following treatment groups are defined for this study: - Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg - Placebo matching darolutamide tablets in appearance, twice daily orally with food ![](page39Picture1.... | [
"Study drugs",
"Background treatment"
] |
NCT02799602 | 7.2 | Identity of study treatment | 7.2 Identity of study treatment | [] |
NCT02799602 | 7.2.1 | Darolutamide and placebo | 7.2.1 Darolutamide and placebo All study drugs will be labeled according to the requirements of local law and legislation. Label text will be approved according to the Sponsor's agreed procedures, and a copy of the labels will be made available to the study site upon request. For all study drugs, a system of numbering ... | [] |
NCT02799602 | 7.2.2 | Background docetaxel treatment | 7.2.2 Background docetaxel treatment Docetaxel is commercially available. The participating investigators are required to consult the product information for docetaxel. All treatment provided by the Sponsor will be labeled according to the requirements of local law and legislation. Label text will be approved according... | [] |
NCT02799602 | 7.3 | Treatment assignment | 7.3 Treatment assignment At the end of the screening period, all subjects meeting all of the inclusion criteria and none of the exclusion criteria will be randomly assigned on a 1:1 basis in a blinded fashion to treatment with darolutamide or matching placebo plus ADT and docetaxel. In addition, randomization will be s... | [] |
NCT02799602 | 7.4 | Dosage and administration of study treatment | 7.4 Dosage and administration of study treatment | [] |
NCT02799602 | 7.4.1 | Dose modifications of study drug | 7.4.1 Dose modifications of study drug The study drug will be administered as oral 300 mg tablets. The dose of study drug to be administered is 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg. Placebo matching darolutamide tablets in appearance will be administered twice ... | [] |
NCT02799602 | 7.4.1.1 | Dose interruption | 7.4.1.1 Dose interruption The maximum time for a dose interruption period is 28 consecutive days. Any subject requiring treatment interruption >28 consecutive days must be withdrawn from treatment with study drug. | [] |
NCT02799602 | 7.4.1.2 | Dose reduction | 7.4.1.2 Dose reduction If considered necessary for subject's safety, the dose of study drug may be reduced to 300 mg bid. The medical monitor must be notified of any darolutamide dose reduction. Dosing of the study drug below 300 mg bid is not allowed. If a Grade 3 or higher treatment-related AE occurs while the subjec... | [] |
NCT02799602 | 7.4.1.3 | General recommendations for dose modifications of study drug | 7.4.1.3 General recommendations for dose modifications of study drug A subject who experiences a treatment–related Grade 3 or 4 AE should interrupt study drug until the AE improves to Grade 2 or less. Treatment with study drug is then to be restarted at 300 mg bid. Additional details are provided in [Table 7–2.](#page-... | [] |
NCT02799602 | 7.4.2 | Dosage and administration for background treatment | 7.4.2 Dosage and administration for background treatment All subjects must receive ADT of Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy. The docetaxel dose to be administered is 75 mg/m2 Day 1 as 1 hour IV infusion every 21 days, in line with the summary of products characteristics... | [] |
NCT02799602 | 7.4.3 | Dose modifications of docetaxel background treatment | 7.4.3 Dose modifications of docetaxel background treatment Dose adjustments of docetaxel should be made based on the specific types of toxicities observed, graded using NCI–CTCAE v4.03. Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3 . In order to monitor the occurrence of neutropenia, wh... | [] |
NCT02799602 | 7.5 | Blinding | 7.5 Blinding Subjects will be randomized to receive darolutamide or matching placebo in a double–blind fashion such that neither the Investigator, nor the Sponsor, nor the subject will know which agent is being administered. The randomization number will be assigned through the IXRS based on information supplied by the... | [
"SUSAR unblinding",
"Emergency unblinding by the Investigator"
] |
NCT02799602 | 7.6 | Drug logistics and accountability | 7.6 Drug logistics and accountability All study drugs will be stored at the investigational site in accordance with Good Clinical Practice (GCP) and GMP requirements and the instructions given by the clinical supplies department of the Sponsor (or its affiliate/contract research organization [CRO]), and will be inacces... | [] |
NCT02799602 | 7.7 | Treatment compliance | 7.7 Treatment compliance Any discrepancies between actual and expected amount of returned study medication must be discussed with the subject at the time of the visit, and any explanation must be documented in the source records. | [] |
NCT02799602 | 8 | Non–study therapy | 8. Non–study therapy | [] |
NCT02799602 | 8.1 | Prior and concomitant therapy | 8.1 Prior and concomitant therapy All subjects must receive an ADT of the Investigator's choice (LHRH agonist/antagonists or orchiectomy) as standard therapy started ≤12 weeks before randomization (if combined with a first–generation anti–androgen, such as bicalutamide, flutamide, nilutamide, or cyproterone acetate, it... | [] |
NCT02799602 | 8.1.1 | Prior therapy | 8.1.1 Prior therapy All medications taken in the first 28 days prior to randomization (including start/stop dates, dose frequency, route of administration, and indication) must be recorded in the subject's source documentation, as well as entered in the appropriate pages of the eCRF. Prior local treatment for prostate ... | [] |
NCT02799602 | 8.1.2 | Permissible concomitant medications and treatments | 8.1.2 Permissible concomitant medications and treatments All concomitant treatments from the time of IC until the end–of–study treatment visit must be recorded on the CRFs. Once the subject has been withdrawn from the treatment with study drug, follow–up treatments will be recorded if used to treat new study drug–relat... | [] |
NCT02799602 | 8.1.3 | Prohibited concomitant medications and treatments | 8.1.3 Prohibited concomitant medications and treatments Concomitant treatment with another systemic antineoplastic therapy or another investigational medicinal product is prohibited with the exception of ADT throughout the study and 6 cycles of docetaxel after randomization. Initiation of the following medications duri... | [] |
NCT02799602 | 8.2 | Post–study therapy | 8.2 Post–study therapy After treatment discontinuation, subjects will enter the Active Follow–up period and then the Long–term (Survival) Follow–up period. Therapy after discontinuation of study treatment will be collected as follows:
During Active Follow–up (includes EOT Visit and Active Follow–up visits): - EOT Visi... | [
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"After primary analysis of the study:"
] |
NCT02799602 | 9 | Procedures and variables | 9. Procedures and variables | [] |
NCT02799602 | 9.1 | Tabular schedule of evaluations | 9.1 Tabular schedule of evaluations All procedures, including efficacy and safety measurements obtained during the course of the study, are summarized in the schedule of assessments ([Table 9–1\)](#page-49-0).  26 MAY 2020 Version 5.0 Page: 49 of 108
Table 9–1 Schedule of assessments | Procedur... | [
"Table 9–1 Schedule of assessments"
] |
NCT02799602 | 9.2 | Visit description | 9.2 Visit description Subject study visits are to occur every 12 weeks (±7 days) starting from randomization. The EOT Visit should occur within a minimum of 30 days (+7 days) after last dose of study drug. The details of these visits are listed in [Table 9–1](#page-49-0). | [] |
NCT02799602 | 9.2.1 | Screening period | 9.2.1 Screening period A prospective study subject will receive both written and verbal information about the study, and will have an opportunity to ask questions and should have sufficient time to decide whether or not to participate in the study. The original signed and dated ICF must be retained in the Investigator'... | [
"Within 7 days before randomization:"
] |
NCT02799602 | 9.2.2 | Study treatment period | 9.2.2 Study treatment period | [] |
NCT02799602 | 9.2.2.1 | Day 1 (Visit 1) | 9.2.2.1 Day 1 (Visit 1) Randomization must occur within 28 days from ICF signature. The subject will arrive at the study center on the morning of Day 1 (+3 days). The first dose of study drug will be administered with breakfast at the study center. The following procedures will be performed: - Medical resource use - Bl... | [
"If not performed at Screening:"
] |
NCT02799602 | 9.2.2.2 | Visit 2 and subsequent visits (every 12 weeks ± 7 days) | 9.2.2.2 Visit 2 and subsequent visits (every 12 weeks ± 7 days) The following procedures will be performed: - Medical resource use - Symptom / QoL questionnaire NCCN–FACT–FPSI–17  26 MAY 2020 Version 5.0 Page: 56 of 108 - Pain questionnaire BPI–SF - Analgesic 24–hour consumption log –eCRF (Physi... | [] |
NCT02799602 | 9.2.2.3 | Requirement for chest, abdomen and pelvic CT/MRI and bone scan during the study treatment period | 9.2.2.3 Requirement for chest, abdomen and pelvic CT/MRI and bone scan during the study treatment period Contrast–enhanced chest, abdomen and pelvic CT or MRI for the assessment of soft tissue/visceral lesions and bone scan for the assessment of bone lesions should be performed at the end of docetaxel treatment (within... | [] |
NCT02799602 | 9.2.3 | Active Follow–up period | 9.2.3 Active Follow–up period
End–of–study treatment visit Subjects will have an EOT Visit 30 days (+7 days) after the last dose of study drug. Another systemic antineoplastic therapy may be initiated no sooner than 7 days after the last dose of study drug. After primary analysis of the study: - Subjects in the darolu... | [
"End–of–study treatment visit",
"Active Follow–up Visits"
] |
NCT02799602 | 9.2.4 | Long–term (survival) Follow–up period | 9.2.4 Long–term (survival) Follow–up period After completing the Active Follow–up period, subjects will enter the Long–term Follow–up period. Subjects will be contacted approximately every 12 weeks by phone, and additional contacts may be required for overall (survival assessment). The following information will be col... | [] |
NCT02799602 | 9.2.5 | Unscheduled visits | 9.2.5 Unscheduled visits In the event that there are significant abnormal safety findings or suspected disease progression, control assessments may be performed at any time during the study treatment period according to the judgment of the Investigator. The following procedures (one or more) may be performed at the uns... | [] |
NCT02799602 | 9.3 | Population characteristics | 9.3 Population characteristics | [] |
NCT02799602 | 9.3.1 | Demographic | 9.3.1 Demographic Demographic characteristics of date of birth (age), sex, and race/ethnicity should be entered in the eCRFs. | [] |
NCT02799602 | 9.3.2 | Medical history | 9.3.2 Medical history Medical history findings (i.e. previous diagnoses, diseases, or surgeries) meeting all criteria listed below will be collected: - Not pertaining to the study indication - Start before signing of the ICF - Considered relevant to the study Detailed instructions on the differentiation between medical... | [] |
NCT02799602 | 9.3.3 | Other baseline characteristics | 9.3.3 Other baseline characteristics Baseline characteristics relating to disease factors include: - QoL assessment (NCCN–FACT FPSI–17) - ECOG PS - Cancer pain assessment All medications and significant non–drug therapies ongoing during the screening period (28 days prior to randomization) must be entered in the eCRF, ... | [] |
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