Rucaparib in Nonmetastatic prOstAte With BRCAness

NCT03533946 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HCI111833
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• 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

Study Arms (1)

Rucaparib, all participants

EXPERIMENTAL

Single Arm study, all participants will get rucaparib

Drug: Rucaparib

Interventions

Rucaparib DRUG

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.

Also known as: Rubraca

Rucaparib, all participants

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-2.
• 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.

You may not qualify if:

• 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.
• Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 28 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

Sponsors & Collaborators

• University of Utah: lead
• Clovis Oncology, Inc.: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Sahu KK, Li H, Mathew Thomas V, Benson M, Boucher K, Gupta S, Kohli M, Swami U, Agarwal N, Maughan BL. A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR). Oncologist. 2024 May 3;29(5):450-e725. doi: 10.1093/oncolo/oyae030.

  PMID: 38452035 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Clinicaltrials.gov and CTRP Specialist
• Organization: Huntsman Cancer Institute/University of Utah

IITDataManagement@hci.utah.edu

8012136215

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 23, 2018
• Study Start: May 20, 2019
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)