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

University of Utah1 site in 1 country7 target enrollmentMay 20, 2019

ConditionsProstate Cancer

InterventionsRucaparib

DrugsRucaparib

Overview

Phase: Phase 2
Intervention: Rucaparib
Conditions: Prostate Cancer
Sponsor: University of Utah
Enrollment: 7
Locations: 1
Primary Endpoint: Prostate Specific Antigen Progression Free Survival
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 20, 2019

End Date

January 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

University of Utah

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Hormone-sensitive, histologically proven adenocarcinoma of the prostate with BRCAness (defined as an alteration in one or more of the following genes: BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, NBN, PALB2, RAD51C, RAD51D, RAD51, RAD51B) from soft-tissue based genomic testing or liquid biopsy based genomic or genetic testing. Pathogenic or likely pathogenic alterations are accepted.
•Eastern Cooperative Oncology Group (ECOG)/Zubrod score of 0-
•At a minimum, subjects must have received definitive local therapy with curative intent (i.e., prostatectomy, and/or radiation therapy) with or without systemic therapy.
•Testosterone level is \> 50 ng/dL.
•Be at least 18 years old at the time the informed consent form is signed.
•Demonstrate adequate organ function as defined in the table in the protocol, all screening labs should be performed within 28 days of treatment initiation.
•Highly effective barrier methods must be used with all sexual activity and contraception methods must be practiced for all subjects throughout the study and for at least 6 months after last rucaparib treatment administration if the risk of conception exists (section 7.2).
•Recovery to baseline or Grade ≤ 1 CTCAE v5.0 from toxicities related to any prior treatments within the context of their definitive local therapy for their prostate cancer, unless Adverse Event(s) (AE)(s) are clinically nonsignificant and/or stable on supportive therapy.
•Subject is able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
•Subject must have confirmed PSA progression based on at least two time points taken at least one week apart to confirm rising trend.

Exclusion Criteria

•Subjects with metastases defined by conventional scans (CT, MRI, Nuclear Medicine (NM) Bone Scan). Disease identified on molecular imaging (e.g. fluciclovine-PET) is not exclusionary.
•Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 90 days prior to screening.
•Pre-existing duodenal stent, recent (within \< 3 months) or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib.
•Inability to swallow tablets.
•Evidence or history of clinically significant bleeding disorder per the determination of the treating investigator.
•Prior systemic therapy within the past 30 days prior to Day 1 (or 5 half-lives of the drug, whichever is shorter).
•Diagnosis of another malignancy within 2 years before first dose of study treatment only if the cancer will either interfere with participant safety or interfere with the primary endpoint, per the judgement of the Principal Investigator. Participants, who have been diagnosed with, superficial skin cancers, or localized, low grade tumors deemed cured or with a prolonged natural history (e.g estimated overall survival \> 5 years) may be included.
•Prior treatment with any poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, mitoxantrone, cyclophosphamide, or any platinum based chemotherapy.
•Clinically significant (i.e., active) cardiovascular disease at the time of enrollment: congestive heart failure (\> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
•Other severe acute or chronic medical conditions including cardiovascular, endocrine, neurologic, pulmonary or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Arms & Interventions

Rucaparib, all participants

Single Arm study, all participants will get rucaparib

Intervention: Rucaparib

Outcomes

Primary Outcomes

Prostate Specific Antigen Progression Free Survival

Time Frame: From baseline to up to 2 years after study treatment discontinuation; actual max approximately 42 months

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.

Secondary Outcomes

Number of Participants With Adverse Events (AEs) Related to Rucaparib(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(At 6 and 12 months after initiation of study therapy)
Overall Survival (OS) at 2 Years(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(From baseline until up to 2 years after study treatment discontinuation; actual max approximately 42 months)