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Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03533946
Recruitment Status : Active, not recruiting
First Posted : May 23, 2018
Last Update Posted : June 27, 2022
Clovis Oncology, Inc.
Information provided by (Responsible Party):
University of Utah

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Rucaparib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Rucaparib

Arm Intervention/treatment
Experimental: Rucaparib, all patients
Single Arm study, all patients will get rucaparib
Drug: 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03533946

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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Clovis Oncology, Inc.
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Responsible Party: University of Utah Identifier: NCT03533946    
Other Study ID Numbers: HCI111833
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

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents