High dose testosterone for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+1 More
High dose testosterone - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will test whether intermittent high-dose testosterone therapy can shrink tumors in men with DNA repair deficiency.

Eligible Conditions
  • Prostate Cancer
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 weeks

12 weeks
PSA response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

CHEK2
1 of 3
CDK12
1 of 3
ATM
1 of 3
Experimental Treatment

51 Total Participants · 3 Treatment Groups

Primary Treatment: High dose testosterone · No Placebo Group · Phase 2

CHEK2
Drug
Experimental Group · 1 Intervention: High dose testosterone · Intervention Types: Drug
CDK12
Drug
Experimental Group · 1 Intervention: High dose testosterone · Intervention Types: Drug
ATM
Drug
Experimental Group · 1 Intervention: High dose testosterone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,473 Previous Clinical Trials
2,741,705 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,691 Patients Enrolled for Prostate Cancer
Robert B. Montgomery, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
3 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Prostate Cancer
14 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have signed an informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information.
You have had an orchiectomy and are receiving gonadal androgen deprivation therapy with GnRH analogues, antagonists or orchiectomy.
Evaluable disease progression by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria.
Presence of metastatic disease on bone or CT scan.
You have a histologically or cytologically confirmed adenocarcinoma of the prostate.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Washington100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
VA Puget Sound Health Care System Seattle Division, Seattle, WA100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%