NCT05806515|RecruitingPhase 2DMCFDA Drug

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

S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized, High Risk Prostate Cancer With Germline BRCA1/2 Mutations

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S2210NCI-2023-02356U10CA180888

Study Type

interventional

Target

Locations

1 country

Sites

133

Timeline

RegisteredApr 2023

StartedMar 2024

CompletionJun 2031

Brief Summary

This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

61mo left

Started Mar 2024

Longer than P75 for phase_2

Geographic Reach

1 country

133 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.3 years study duration

Study Progress30%

Mar 2024Jun 2031

First Submitted

Initial submission to the registry

March 28, 2023

Completed

13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed

11 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected

3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

March 28, 2023

Last Update Submit

January 28, 2026

Conditions

Prostate Adenocarcinoma Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Pathologic complete response after neoadjuvant carboplatin
A two-stage design will be used.
Up to 5 years

Study Arms (1)

Treatment (carboplatin)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionDrug: CarboplatinProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: PSMA PET ScanProcedure: Surgical Procedure

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (carboplatin)

CarboplatinDRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (carboplatin)

Chest RadiographyPROCEDURE

Undergo chest X-ray

Also known as: Chest X-ray

Treatment (carboplatin)

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (carboplatin)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (carboplatin)

PSMA PET ScanPROCEDURE

Undergo PSMA PET

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Treatment (carboplatin)

Surgical ProcedurePROCEDURE

Undergo surgery

Also known as: Operation, Surgery, Surgery Type, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Treatment (carboplatin)

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participant must have histologic diagnosis of prostate adenocarcinoma
Participant must have high or very high-risk disease defined by at least one of the following:
cT3a - cT4x
Grade group 4 or 5 (Gleason sum 8-10)
PSA \> 20 ng/mL prior to registration
Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab
NOTE: Local lab report is sufficient for eligibility
Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration
Participant must be \>= 18 years old
Participant must have Zubrod performance status of 0-2
Participant must have a complete medical history and physical exam within 28 days prior to registration
Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to registration)
Participant must have a serum creatinine =\< the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance \>= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
+11 more criteria

You may not qualify if:

Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of disease to be potentially completely resectable
Participant must not have received prior radiation therapy (RT) to the pelvic region
Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (133)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

RECRUITING

Alaska Breast Care and Surgery LLC