Metastatic Prostate Cancer study: High dose testosterone
Official title High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
ClinicalTrials.gov ID: NCT05011383
What this study is testing
What is High dose testosterone?
This is an investigational monthly injection being studied as a potential treatment for metastatic prostate cancer.
Also referred to as Bipolar androgen therapy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study tests whether men whose tumors have DNA repair gene changes (ATM, CDK12, CHEK2) are more likely to respond to intermittent high‑dose testosterone therapy.
- Who it's for
- Men with metastatic prostate cancer whose tumors have alterations in the ATM, CDK12 or CHEK2 genes.
- What's involved
- Participants will receive intermittent high‑dose testosterone and will attend scheduled clinic visits for monitoring and tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and...
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy.
- PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.
- Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
You likely can't join if
- Currently receiving active therapy for other neoplastic disorders will not be eligible
- Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic...
- Known parenchymal brain metastasis
- Liver metastases
- Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \> 2.5 x ULN or total bilirubin \> ULN (unless Gilbert's syndrome is the...
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable...
See the full eligibility criteria
- Signed 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
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy.
- PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.
- Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
- Progression of metastatic bone disease on bone scan with \> 2 new lesions
- Presence of metastatic disease on bone or CT scan
- Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.)
- Asymptomatic or minimal cancer related symptoms
- Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2
- Presence of inactivating mutations in ATM, CDK12 or CHEK2 as determined by a CLIA level assay for DNA sequencing
- Currently receiving active therapy for other neoplastic disorders will not be eligible
- Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic evidence is not exclusionary)
- Known parenchymal brain metastasis
- Liver metastases
- Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \> 2.5 x ULN or total bilirubin \> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia)
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease...
- Patients with pain attributable to their prostate cancer and requiring the use of opioids
- Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll.
- Presence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding and/or giving of informed consent
- Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- West Haven, Connecticut, United States
- Gainesville, Florida, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Louisville, Kentucky, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Salisbury, North Carolina, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; West Haven, Connecticut, United States; Gainesville, Florida, United States; Orlando, Florida, United States; Decatur, Georgia, United States; Louisville, Kentucky, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.