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Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR)

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ClinicalTrials.gov Identifier: NCT03533946
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
University of Utah

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE May 23, 2018
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE August 8, 2018
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03533946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • 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.
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rucaparib in Nonmetastatic prOstAte With BRCAness
Official Title  ICMJE A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)
Brief Summary This is a single arm, open label, phase II trial to assess efficacy of rucaparib.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Rucaparib, all patients
Single Arm study, all patients will get rucaparib
Intervention: Drug: Rucaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate with BRCAness (defined as an alteration in one or more of the following genes: 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.
  • ECOG/Zubrod score of 0-2.
  • Subjects must have received definitive local therapy, which includes prostatectomy or radiation therapy with curative intent. Neoadjuvant or adjuvant treatments can have been given within this time.
  • Subject must not have received any prior systemic therapy for localized prostate cancer unless used in the context of definitive local therapy. Patients may receive salvage hormone therapy with radiotherapy, as long as salvage hormone therapy does not exceed 6 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 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.

Exclusion Criteria:

  • Completed any hormone therapy for localized prostate cancer and have recovery of testosterone (i.e. testosterone level is >50ng/dL).
  • Subjects with metastases defined by conventional scans (CT, MRI, NM Bone Scan). Disease identified on molecular imaging (e.g. fluciclovine-PET) is not exclusionary.
  • Prior salvage therapy for prostate cancer treatment with chemotherapy, 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.
  • Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured or with a prolonged natural history (e.g estimated overall survival > 5 years).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill Broghammer 801-213-6232 jill.broghammer@hci.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03533946
Other Study ID Numbers  ICMJE HCI111833
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Clovis Oncology, Inc.
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP