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Trial record 2 of 33 for:    rucaparib

Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR)

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ClinicalTrials.gov Identifier: NCT03533946
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 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)
Primary Purpose: Treatment
Official Title: A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)
Estimated Study Start Date : July 2018
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. 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.



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. 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

  3. 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.




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

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate with BRCAness (defined as a deleterious alteration in one or more of the following genes: ATM, ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, ERCC3, FAM175A, FANCA, FANCL, GEN1, HDAC2, MLH1, MRE11, NBN, PALB2, PPP2R2A, RAD51, RAD54L) from soft-tissue based genomic testing or liquid biopsy based genomic testing.
  • Rising PSA based on PCWG3 criteria without radiographic evidence of metastatic disease as assessed by CT scans and technetium nuclear medicine bone scan. Subject must demonstrate a PSA doubling time of ≤ 10 months.
  • ECOG/Zubrod score of 0-2.
  • Subject must not have received any prior systemic therapy for prostate cancer except for adjuvant hormone treatment in the context of localized prostate cancer. Patients may have not received ADT treatment longer than 24 months.
  • Be 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 (surgery, radiotherapy or other antineoplastic therapy), unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Last dose of any antineoplastic therapy ≥ 2 weeks (including neoadjuvant chemotherapy, radiation therapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents).
  • Subject is participating in the Total Cancer Care study (IRB # 89989).
  • Subject is able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

  • ADT therapy either by surgical castration or with GnRH agonist or antagonist or on androgen synthesis blocker or androgen receptor antagonists previously for the treatment of biochemically recurrent prostate cancer.
  • Prior localized prostate cancer treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or angiogenesis inhibitors.
  • Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months prior to screening.
  • Pre-existing duodenal stent, recent 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 bleeding disorder.
  • Participation in another investigational drug trial within 14 days prior to Day 1 (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to Day 1.
  • Acute illness (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to Day 1, unless mild in severity and approved by the Principal Investigator.
  • Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer with curative intent.
  • Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide, or any platinum based chemotherapy.
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, 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.

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03533946     History of Changes
Other Study ID Numbers: HCI111833
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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