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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02975934




Registration number
NCT02975934
Ethics application status
Date submitted
19/11/2016
Date registered
29/11/2016

Titles & IDs
Public title
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Scientific title
TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency
Secondary ID [1] 0 0
CO-338-063
Universal Trial Number (UTN)
Trial acronym
TRITON3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rucaparib
Treatment: Drugs - Abiraterone acetate or Enzalutamide or Docetaxel

Experimental: Rucaparib - Oral rucaparib (monotherapy).

Active comparator: Abiraterone acetate or Enzalutamide or Docetaxel - Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).


Treatment: Drugs: Rucaparib
Rucaparib will be administered daily.

Treatment: Drugs: Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
Timepoint [1] 0 0
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Primary outcome [2] 0 0
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
Timepoint [2] 0 0
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary outcome [1] 0 0
Interim Overall Survival in Participants With a BRCA Alteration
Timepoint [1] 0 0
From enrollment to primary completion of study (up to approximately 5 years)
Secondary outcome [2] 0 0
Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined
Timepoint [2] 0 0
From enrollment to primary completion of study (up to approximately 5 years)
Secondary outcome [3] 0 0
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
Timepoint [3] 0 0
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary outcome [4] 0 0
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
Timepoint [4] 0 0
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary outcome [5] 0 0
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
Timepoint [5] 0 0
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary outcome [6] 0 0
Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
Timepoint [6] 0 0
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary outcome [7] 0 0
PSA Response in Participants With a BRCA Alteration
Timepoint [7] 0 0
From enrollment to primary completion of study (up to approximately 5 years)
Secondary outcome [8] 0 0
PSA Response in Participants With a BRCA or ATM Alteration Combined
Timepoint [8] 0 0
From enrollment to primary completion of study (up to approximately 5 years)
Secondary outcome [9] 0 0
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
Timepoint [9] 0 0
From enrollment to 6 months
Secondary outcome [10] 0 0
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
Timepoint [10] 0 0
From enrollment to 6 months
Secondary outcome [11] 0 0
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
Timepoint [11] 0 0
From enrollment to primary completion of study (up to approximately 5 years)
Secondary outcome [12] 0 0
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
Timepoint [12] 0 0
From enrollment to primary completion of study (up to approximately 5 years)
Secondary outcome [13] 0 0
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
Timepoint [13] 0 0
From enrollment to up to approximately 25 weeks
Secondary outcome [14] 0 0
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
Timepoint [14] 0 0
From enrollment to up to approximately 25 weeks
Secondary outcome [15] 0 0
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
Timepoint [15] 0 0
From enrollment to up to approximately 25 weeks
Secondary outcome [16] 0 0
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
Timepoint [16] 0 0
From enrollment to week 5 of dosing

Eligibility
Key inclusion criteria
* Be 18 years old at the time the informed consent is signed
* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
* Be surgically or medically castrated, with serum testosterone levels of = 50 ng/dL (1.73 nM)
* Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
* Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy
* Have a deleterious mutation in a BRCA1/2 or ATM gene
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
* Prior treatment with any PARP inhibitor
* Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
405
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Southside Cancer Care Centre - Miranda
Recruitment hospital [2] 0 0
Orange Health Service - Orange
Recruitment hospital [3] 0 0
Northern Cancer Insitute, St. Leonards - Saint Leonards
Recruitment hospital [4] 0 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [5] 0 0
Peninsula & Southeast Oncology - Frankston
Recruitment hospital [6] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
2650 - Wagga Wagga
Recruitment outside Australia
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Alabama
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Arizona
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London
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Taunton
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
pharmaand GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Foundation Medicine
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by zr pharma\& Austria GmbH

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
Available to whom?
Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@pharmaand.com.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermo... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02975934