Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Rucaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Single Arm study, all participants will get rucaparib

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.

This is a single arm, open label, phase II trial to assess efficacy of rucaparib.

This is a single arm, open label, phase II trial to assess efficacy of rucaparib

Rucaparib in Nonmetastatic prOstAte With BRCAness

A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)

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.

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.

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.

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.

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.

Clovis Oncology, Inc.

University of Utah

Adverse events were assessed at each study visit (approximately monthly). The occurrence of adverse events was sought by non-directive questioning of the participant at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the participant during or between visits or through physical examination, laboratory test, or other assessments.

Single Arm study, all participants will get rucaparib.

Rucaparib, All Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Clinicaltrials.gov and CTRP Specialist

Prostate Specific Antigen Progression Free Survival

Grade 1

Grade 2

Grade 3

Number of Participants With Adverse Events (AEs) Related to Rucaparib

At 6 months

At 12 months

Three participants did not complete follow-up to 6 months, so only four could be evaluated.

Spots Global Cancer Trial Database for Rucaparib in Nonmetastatic prOstAte With BRCAness

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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