Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR)
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|ClinicalTrials.gov Identifier: NCT03533946|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Rucaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single arm, open label, phase II trial to assess efficacy of rucaparib|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: Rucaparib, all patients
Single Arm study, all patients will get rucaparib
Treatment with rucaparib will begin on Cycle 1 Day 1 and continue at 600 mg twice daily. Therapy continues until PSA progression or intolerable toxicities.
Other Name: Rubraca
- 50% Reduction in PSA levels [ Time Frame: Monthly while on treatment; Most patients are expected to be on treatment for approximately 18 months ]
To assess the proportion of patients with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment.
Endpoint: the levels of PSA will be monitored monthly for comparison to baseline levels.
- Adverse Events that Occur [ Time Frame: Every visit while on treatment and 1 year of follow-up - Most patients are expected to be on treatment for approximately 18 months, and then one additional year ]
To assess the safety of rucaparib in patients with biochemically recurrent hormone-sensitive prostate cancer.
Endpoint: adverse events will be monitored regularly during patient enrollment and follow up to assess the toxicity of rucaparib using validated CTCAE v5.0 criteria.
- PSA Progression Free Survival [ Time Frame: Monthly while on treatment; Most patients are expected to be on treatment for approximately 18 months ]The levels of PSA will be monitored monthly for comparison to baseline levels until the time of PSA progression, as defined by Prostate Cancer Working Group 3 (PCWG3) criteria
- Proportion of patients with an undetectable PSA after initiation at therapy [ Time Frame: At 6 and 12 months ]
To assess the proportion of patients with an undetectable PSA after initiation of PARP therapy at 6 and 12 months.
Endpoint: the levels of PSA will be monitored monthly for comparison to baseline levels to determine when PSA becomes undetectable.