This is a single arm, open label, phase II trial to assess efficacy of rucaparib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Treatment with rucaparib will begin on Cycle 1 Day 1 and continue at 600 mg twice daily. Therapy continues until Prostate Specific Antigen (PSA) progression or intolerable toxicities.
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Prostate Specific Antigen Progression Free Survival
The levels of PSA were monitored monthly for comparison to baseline levels until the time of PSA progression, or 2 years after study treatment discontinuation, or study termination, as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. PCWG3 criteria for PSA progression is a rise over baseline of \>= 25% and an absolute rise of \>= 2 ng/mL. Reported as median number of months from baseline to PSA progression.
Time frame: From baseline to up to 2 years after study treatment discontinuation; actual max approximately 42 months
Number of Participants With Adverse Events (AEs) Related to Rucaparib
To assess the safety of rucaparib in participants with biochemically recurrent hormone-sensitive prostate cancer. Severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity, where Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE." Each adverse event was also evaluated by the treating investigator to assess its attribution to rucaparib, with options being unrelated, unlikely related, possibly related, probably related, or definitely related to rucaparib. Possibly, probably, and definitely related were grouped together as "Related." Reported here are the number of participants with any related AE of the specified grade. Note that there were no Grade 4 or Grade 5 related AEs.
Time frame: From first dose of study treatment until 30 days after last dose of study treatment; max 42 months
Count of Participants With an Undetectable PSA at 6 and 12 Months
To assess the percentage of participants with an undetectable PSA after initiation of study 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. Participants who were not followed for at least 6 months after initiation of study therapy were not able to be evaluated for this time point.
Time frame: At 6 and 12 months after initiation of study therapy
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Overall Survival (OS) at 2 Years
To evaluate OS in nonmetastatic hormone-sensitive prostrate cancer participants treated with rucaparib. Calculated as the number of participants alive 2 years after study treatment discontinuation or study termination.
Time frame: From start of study treatment until up to 2 years after study treatment discontinuation; actual max approximately 42 months
Count of Participants With 50% or Greater Reduction in PSA Levels
To assess the number of participants with a 50% reduction in PSA levels (PSA50) compared to the baseline value at the time of study enrollment. The levels of PSA will be monitored monthly for comparison to baseline levels.
Time frame: From baseline until up to 2 years after study treatment discontinuation; actual max approximately 42 months