Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR)
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|ClinicalTrials.gov Identifier: NCT03533946|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2018
Last Update Posted : June 27, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Rucaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 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 :||May 20, 2019|
|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
- 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
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 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.
- Subjects with metastases defined by conventional scans (CT, MRI, 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 patient safety or interfere with the primary endpoint, per the judgement of the Principal Investigator. Patients, 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 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 patient 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.
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
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Responsible Party:||University of Utah|
|Other Study ID Numbers:||
|First Posted:||May 23, 2018 Key Record Dates|
|Last Update Posted:||June 27, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
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