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High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

NCT05011383 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-09

No results posted yet for this study

Summary

This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis

Conditions

Interventions

DRUG

High dose testosterone

High dose testosterone is administered subcutaneously once monthly until progression or toxicity

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Robert B. Montgomery, MD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05011383 on ClinicalTrials.gov