Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR)
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|ClinicalTrials.gov Identifier: NCT03533946|
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : June 19, 2019
|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)|
|Actual Study Start Date :||August 8, 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.
- Overall Survival [ Time Frame: Every 3 months for 2 years after study discontinuation ]To evaluate overall survival (OS) in nonmetastatic hormone-sensitive prostrate cancer patients treated with rucaparib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533946
|Contact: Jill Broghammeremail@example.com|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Jill Broghammer 801-213-6232 firstname.lastname@example.org|
|Principal Investigator: Benjamin Maughan, MD|