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PARP Inhibitor
Rucaparib for Prostate Cancer (TRIUMPH Trial)
Phase 2
Waitlist Available
Led By Mark Markowski, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male participants and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination [see appendix E for acceptable methods], throughout the period of taking study treatment and for 6 months after last dose of study drug to prevent pregnancy in a partner.
ECOG Performance Status <2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
TRIUMPH Trial Summary
This trial will study if the study drug rucaparib can help to lower PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy and who have an inherited mutation in a gene involved in repairing DNA damage.
Who is the study for?
Men over 18 with metastatic prostate cancer, a germline DNA repair gene mutation, and no prior hormone therapy are eligible. They must have normal organ function, not be on certain medications or have had recent major surgery, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing if rucaparib can lower PSA levels in men with metastatic hormone-sensitive prostate cancer who haven't started testosterone-lowering drugs yet but have inherited mutations in DNA repair genes.See study design
What are the potential side effects?
Rucaparib may cause side effects like nausea, fatigue, blood count issues, increased risk of infection or inflammation of organs. Specific reactions vary by individual.
TRIUMPH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male and will use two effective birth control methods during and 6 months after treatment.
Select...
I can do most of my daily activities without help.
Select...
I have a genetic mutation linked to cancer, confirmed by a clinical test.
Select...
I cannot or have chosen not to undergo hormone therapy for my cancer.
Select...
My kidneys work well enough, based on a specific test.
Select...
My prostate cancer diagnosis was confirmed through tissue analysis.
Select...
I am a man aged 18 or older.
TRIUMPH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate(PSA)to rucaparib for pts with met. hormone sensitive prostate ca harboring germline mutation in homologous recombination DNA repair gene. Measured by decline in PSA to 50% of baseline, confirmed w/second measurement at least 4 weeks apart.
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Objective response rate, defined as the proportion of patients achieving a complete or partial response in target lesions found on radiographic scans
PSA progression-free survival, defined as a time from initiation of rucaparib therapy until PSA increase of 25 %, confirmed with another measurement at least 3 weeks later
+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%
General physical health deterioration
1%
Incarcerated hernia
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
TRIUMPH Trial Design
1Treatment groups
Experimental Treatment
Group I: Rucaparib 600 mg BID, continuous dosingExperimental Treatment1 Intervention
Rucaparib 600mg by mouth twice daily, continuous dosing
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?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
559 Previous Clinical Trials
32,969 Total Patients Enrolled
58 Trials studying Prostate Cancer
3,428 Patients Enrolled for Prostate Cancer
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,641 Total Patients Enrolled
3 Trials studying Prostate Cancer
311 Patients Enrolled for Prostate Cancer
Mark Markowski, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active cancer except for non-melanoma skin or superficial bladder cancers.I have large cancer spread to my lung or liver.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I haven't taken any anti-androgen or androgen synthesis inhibitors in the last 6 months, but I may have been on stable 5-alpha reductase inhibitor therapy.I do not have any serious, uncontrolled health issues that would make me a poor medical risk.I am a male and will use two effective birth control methods during and 6 months after treatment.I need strong painkillers for my cancer-related bone pain.I have had chemotherapy through an IV before.I haven't taken any medications that could interfere with the study in the last 2 weeks.I have never been treated with a PARP inhibitor.My heart's electrical activity is irregular, or I have a family history of long QT syndrome.I have a genetic mutation linked to cancer, confirmed by a clinical test.I cannot or have chosen not to undergo hormone therapy for my cancer.My scans from the last 8 weeks show cancer has spread.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.My kidneys work well enough, based on a specific test.I cannot swallow pills or have stomach issues affecting medicine absorption.I can do most of my daily activities without help.I had major surgery more than 2 weeks ago and have recovered from it.My prostate cancer diagnosis was confirmed through tissue analysis.I have lasting side effects from cancer treatment, but not hair loss.I am a man aged 18 or older.My organ and bone marrow functions are normal as tested within the last 28 days.I have not received a blood transfusion in the last 30 days.I have not had hormone therapy for cancer in the last 6 months, but my testosterone levels are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Rucaparib 600 mg BID, continuous dosing
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.
Have other researchers looked into this treatment method before?
"Rucaparib is currently being trialed in 35 active studies across 861 cities and 34 countries. The first clinical trial began in 2014, completed Phase 3 drug approval in the same year, and was sponsored by Clovis Oncology, Inc. A total of 564 patients were involved. In the 6 years since then, 15 more Rucaparib trials have been conducted."
Answered by AI
What is the official position of the FDA on Rucaparib?
"Our analysts have given Rucaparib a safety score of 2. This is due to Phase 2 trials only having data supporting safety, and no efficacy data currently available."
Answered by AI
Could you please provide a list of other medical trials that have used Rucaparib?
"The first clinical trial for rucaparib was at Sourasky Medical Center in 2014. As of right now, there have been a total of 15 completed trials and 35 active ones. A large number of these tests are being conducted in Baltimore, Maryland."
Answered by AI
Are new patients being enrolled in this experiment?
"The trial, which is currently recruiting patients, was originally posted on September 10th 2018. The most recent update to the study occurred on June 10th 2022."
Answered by AI
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