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PARP Inhibitor
Rucaparib for Prostate Cancer (ROAR Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 and 12 months after initiation of study therapy
Awards & highlights
ROAR Trial Summary
This trial will assess whether rucaparib is effective in treating patients with solid tumors.
Who is the study for?
Men over 18 with hormone-sensitive prostate cancer showing BRCAness from specific gene alterations, who've had local therapy (like surgery or radiation) and have recovered from previous treatments. They must not have metastases visible on standard scans, no recent other cancers or major surgeries, and be able to swallow tablets. An ECOG/Zubrod score of 0-2 is required.Check my eligibility
What is being tested?
The trial is testing the effectiveness of rucaparib, a drug for prostate cancer in men whose tumors show certain genetic changes known as BRCAness. It's an open-label phase II study where all participants receive the same treatment without a comparison group.See study design
What are the potential side effects?
Rucaparib may cause side effects like nausea, fatigue, blood count changes leading to infections or bleeding problems, liver enzyme elevations indicating potential liver issues, and gastrointestinal symptoms such as constipation or diarrhea.
ROAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 and 12 months after initiation of study therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 and 12 months after initiation of study therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate Specific Antigen Progression Free Survival
Secondary outcome measures
Count of Participants With 50% or Greater Reduction in PSA Levels
Count of Participants With an Undetectable PSA at 6 and 12 Months
Number of Participants With Adverse Events (AEs) Related to Rucaparib
+1 moreSide effects data
From 2022 Phase 3 trial • 564 Patients • NCT0196821376%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Pruritus
15%
Rash
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Anxiety
8%
Neutrophil count decreased
8%
Hypercholesterolaemia
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
Incarcerated hernia
1%
General physical health deterioration
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets
ROAR Trial Design
1Treatment groups
Experimental Treatment
Group I: Rucaparib, all participantsExperimental Treatment1 Intervention
Single Arm study, all participants will get rucaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
2016
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,097 Previous Clinical Trials
1,778,598 Total Patients Enrolled
7 Trials studying Prostate Cancer
5,342 Patients Enrolled for Prostate Cancer
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,664 Total Patients Enrolled
2 Trials studying Prostate Cancer
304 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a blockage or problem with your digestive system that could affect how well your body absorbs rucaparib.You have experienced a blood clot in your arteries or veins, a stroke, a heart attack, or had a procedure for heart blockage within the past 90 days.You cannot swallow pills.You have received treatment with certain types of medications before, including PARP inhibitors, mitoxantrone, cyclophosphamide, or platinum-based chemotherapy.You have a bleeding disorder that is considered significant by the doctor in charge of the study.You have serious medical conditions like heart, hormone, brain, lung, or mental health problems that could make it risky for you to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Rucaparib, all participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is the ingestion of Rucaparib for individuals?
"The safety of Rucaparib is assessed at 2 on our scale. This Phase 2 trial has established some data that suggests it may be safe, though efficacy needs to still be confirmed."
Answered by AI
Is this a pioneering attempt at therapeutic treatment?
"Presently, there are 34 active trials for Rucaparib taking place in 831 different cities and spanning 34 countries. This drug was first tested in a clinical trial sponsored by Clovis Oncology Inc., which concluded its Phase 2 approval procedure with 924 patients back in 2015. Since then, 15 more studies have been completed related to the pharmaceutical."
Answered by AI
How many participants are being recruited for this experiment?
"This medical research is no longer accepting patients. It was first posted on May 20th 2019 and its most recent update occurred on June 23rd 2022. Those seeking clinical trials related to prostate cancer can explore 1321 studies, while those looking into Rucaparib have 34 options available."
Answered by AI
Is this research project currently enrolling participants?
"Unfortunately, this clinical trial is not presently accepting patients. It was originally posted on May 20th 2019 and had its last update June 23rd 2022. Despite the closure of this study, online databases report 1355 other trials actively recruiting individuals currently."
Answered by AI
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