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Hormone Therapy
Rucaparib for Prostate Cancer (TRITON3 Trial)
Phase 3
Waitlist Available
Research Sponsored by Clovis Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to primary completion of study (up to approximately 5 years)
Awards & highlights
TRITON3 Trial Summary
This trial will compare the effects of rucaparib to those of other standard treatments for men with metastatic prostate cancer that has continued to grow despite castration and other treatments.
Who is the study for?
This trial is for men over 18 with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They must have specific gene mutations (BRCA1/2 or ATM), have tried one previous treatment, but not had chemotherapy for metastatic cancer, PARP inhibitors, or have other active cancers.Check my eligibility
What is being tested?
The study compares the effectiveness of Rucaparib against a choice of three standard treatments: Abiraterone acetate, Enzalutamide, or Docetaxel in treating prostate cancer that's resistant to castration and shows certain genetic changes.See study design
What are the potential side effects?
Rucaparib may cause nausea, fatigue, blood count issues leading to anemia or infection risk increase. Standard treatments can also cause side effects like weakness, hormonal imbalances from Abiraterone acetate; seizures from Enzalutamide; hair loss and nail changes from Docetaxel.
TRITON3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My testosterone levels are low due to treatment or surgery.
Select...
My prostate cancer has spread and is confirmed by lab tests.
Select...
I am eligible for treatment with either abiraterone, enzalutamide, or docetaxel.
Select...
I am at least 18 years old.
Select...
My cancer progressed after one specific hormone therapy.
Select...
I have a harmful change in my BRCA1/2 or ATM gene.
TRITON3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to primary completion of study (up to approximately 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to primary completion of study (up to approximately 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
Secondary outcome measures
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
+13 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
TRITON3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RucaparibExperimental Treatment1 Intervention
Oral rucaparib (monotherapy).
Group II: Abiraterone acetate or Enzalutamide or DocetaxelActive Control1 Intervention
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
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?
Clovis Oncology, Inc.Lead Sponsor
64 Previous Clinical Trials
11,266 Total Patients Enrolled
3 Trials studying Prostate Cancer
311 Patients Enrolled for Prostate Cancer
pharmaand GmbHLead Sponsor
21 Previous Clinical Trials
3,770 Total Patients Enrolled
zr Pharma & GmbHLead Sponsor
20 Previous Clinical Trials
3,687 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Rucaparib
- Group 2: Abiraterone acetate or Enzalutamide or Docetaxel
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is Rucaparib's current stage in the FDA approval process?
"There is available data that supports the efficacy of Rucaparib and because this is a Phase 3 trial, there is also multiple rounds of data that support the safety of Rucaparib-- leading our team to score it a 3."
Answered by AI
What are the primary applications for Rucaparib?
"Rucaparib is frequently used to treat malignant neoplasms, which are cancerous growths. It is also approved for the treatment of sarcoma, advanced ovarian cancer, and other conditions."
Answered by AI
How many facilities are in charge of this clinical trial?
"There are 46 sites participating in this study, located in cities such as Houston, Honolulu, and Seattle."
Answered by AI
Do we have any precedents for Rucaparib's efficacy?
"522 medical trials are currently underway to research Rucaparib. Of these, 174 are in Phase 3. Most of these studies are taking place in Germantown, Tennessee; however, there are 33498 total locations running Rucaparib trials."
Answered by AI
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