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Alkylating agents

Chemotherapy + Rucaparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Heather H. Cheng
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented evidence of at least ONE or MORE of the following: Pathogenic mutation or inactivating alteration of a gene involved in homologous recombination repair in the tumor
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN; if liver metastases, then =< 5 x ULN (within 14 days of first dose of study drug)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of docetaxel/carboplatin to the date that a >= 25% increase and absolute increase of >= 2 ng/ml above the nadir (or baseline value for patients who did not have a decline in psa) in psa was measured, assessed up to 6 years
Awards & highlights

Study Summary

This trial studies how well a combination of docetaxel, carboplatin, and rucaparib camsylate works in treating patients with metastatic prostate cancer that is resistant to testosterone suppression and has defects in the ability to repair mistakes in DNA.

Who is the study for?
Men with metastatic castration resistant prostate cancer and DNA repair deficiencies (like BRCA mutations) are eligible. They must be on hormone therapy, have no recent platinum chemotherapy or PARP inhibitors, and not suffer from severe heart disease or other conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing a combination of chemotherapy drugs docetaxel and carboplatin followed by rucaparib camsylate maintenance therapy to see if it's effective for prostate cancer patients who can't fix DNA damage well.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, allergic reactions to the drugs, and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific genetic change related to DNA repair.
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My liver enzymes are within the required limits for the study.
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My scans show I have bone disease.
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My prostate cancer is growing despite low testosterone levels.
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I am on hormone therapy for cancer or have had surgery to remove my testicles.
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My scans show cancer has spread to my bones or other parts.
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My tumor has a specific genetic feature found by a special test.
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My prostate cancer is confirmed by lab tests but not mainly small cell type.
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I have a genetic mutation in BRCA1, BRCA2, ATM, or PALB2.
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I am fully active or have some restrictions but can still care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of docetaxel/carboplatin to the date that a >= 25% increase and absolute increase of >= 2 ng/ml above the nadir (or baseline value for patients who did not have a decline in psa) in psa was measured, assessed up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of docetaxel/carboplatin to the date that a >= 25% increase and absolute increase of >= 2 ng/ml above the nadir (or baseline value for patients who did not have a decline in psa) in psa was measured, assessed up to 6 years for reporting.

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 assessed by assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) criteria
Secondary outcome measures
Overall response rate (ORR) of measurable disease (PCWG3) (complete response or partial response) assessed by modified RECIST version 1.1 criteria
PSA nadir after maintenance
PSA response duration
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (docetaxel, carboplatin, rucaparib camsylate)Experimental Treatment5 Interventions
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Carboplatin
2014
Completed Phase 3
~6670
Rucaparib
2016
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,333 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
Heather H. ChengPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
2,464 Total Patients Enrolled
1 Trials studying Prostate Cancer
450 Patients Enrolled for Prostate Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03442556 — Phase 2
Prostate Cancer Research Study Groups: Treatment (docetaxel, carboplatin, rucaparib camsylate)
Prostate Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03442556 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03442556 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in this research?

"That is correct. The information available on clinicaltrials.gov indicates that the trial is still recruiting patients. 20 individuals are needed for the study, which is being conducted at a single location."

Answered by AI

What are some of the primary maladies that Docetaxel has been shown to ameliorate?

"Docetaxel has shown to be effective in the treatment of melanoma, head and soft tissue sarcoma."

Answered by AI

Are there any parallel investigations to the Docetaxel study?

"There are presently 1030 clinical trials registered for Docetaxel with 343 of them in Phase 3. The international study is being conducted in 66318 locations, with many of the research centres based in Columbus, Ohio."

Answered by AI

How does Docetaxel impact patients' safety?

"While there is some safety data surrounding Docetaxel, it only received a 2 because Phase 2 trials have not yet demonstrated efficacy."

Answered by AI

Are there any positions still available for participants in this clinical trial?

"This trial, which is currently recruiting patients, was first posted on 8/24/2018 and was last updated on 6/10/2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency
2018. "Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03442556.
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~3 spots leftby May 2025
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