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Alkylating agents

Treatment (carboplatin) for Prostate Adenocarcinoma

Phase 2

Recruiting

Led By Heather H Cheng

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Grade group 4 or 5 (Gleason sum 8-10)

cT3a - cT4x

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests if carboplatin before surgery can shrink prostate tumors in patients with high-risk cancer who have the BRCA1/2 gene mutation. Carboplatin kills/slows tumor growth similar to cisplatin but may be better tolerated.

Who is the study for?

This trial is for men over 18 with high-risk prostate cancer and a BRCA1 or BRCA2 gene mutation. They should have advanced cancer (stage cT3a - cT4x, Gleason sum 8-10) and a PSA level over 20 ng/mL. Participants can be on certain hormone treatments but must not extend beyond one month after joining the study.Check my eligibility

What is being tested?

The trial is testing if giving Carboplatin, a platinum-containing chemotherapy drug, before surgery can shrink tumors in patients with high-risk prostate cancer who also carry the inherited BRCA gene mutations.See study design

What are the potential side effects?

Carboplatin may cause side effects like nausea, vomiting, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, tiredness, kidney issues and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is high grade (Gleason score 8-10).

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My cancer is classified between stages cT3a to cT4x.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have been diagnosed with prostate cancer.

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I am 18 years old or older.

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I have a confirmed BRCA1 or BRCA2 mutation from a certified lab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Pathologic complete response after neoadjuvant carboplatin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carboplatin)Experimental Treatment7 Interventions

Patients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Carboplatin

2014

Completed Phase 3

~6670

Chest Radiography

2018

N/A

~560

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

PSMA PET Scan

2020

N/A

~10

Surgical Procedure

2020

Completed Phase 2

~160

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,767 Total Patients Enrolled

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

265,126 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,397 Total Patients Enrolled

Frequently Asked Questions

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

In what areas can participants access the trial?

"Presently, this clinical trial is enrolling patients at 133 sites across the nation - such as Anaconda, Anchorage and Phoenix. To reduce any travel burden on participants, it may be best to select a location near you for convenience sake."

Answered by AI

Has carboplatin received the green light from the Food and Drug Administration?

"After careful evaluation, our team assigned Treatment (carboplatin) a rating of 2 due to the lack of clinical evidence for efficacy in Phase 2 trials and some data supporting safety."

Answered by AI

Is there still an opportunity to volunteer for this experiment?

"As evidenced on clinicaltrials.gov, the study is no longer recruiting participants since December 6th 2023. However, there are 1280 other trials that have current openings for volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation

2024. "Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05806515.

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