Actively Recruiting
Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-17
12
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.
CONDITIONS
Official Title
Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic castration-resistant prostate cancer with no grade 2 or higher cancer-related symptoms
- Evidence of PSA or imaging progression at castrate levels of serum testosterone (<50 ng/dl) according to PCWG3 criteria
- Positive PSMA PET scan and eligibility for PSMA-617 treatment
- Prior treatment with one line of androgen receptor pathway inhibitor for at least 4 weeks
- Prior treatment with sipuleucel-T for mCRPC or docetaxel in the castration sensitive setting
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function
- History of prior or concurrent malignancy that will not interfere with safety or efficacy assessments
- History of myocardial infarction or congestive heart failure with left ventricle ejection fraction above 40% within 6 months prior to enrollment
- Non-sterilized men sexually active with female partners of childbearing potential must agree to use adequate contraception during and 6 weeks after treatment
- Ability and willingness to provide informed consent and comply with study procedures and duration
You will not qualify if you...
- Presence of metastatic prostate cancer with known epidural, liver, or brain metastases
- History of spinal cord compression
- Radiation treatment within 30 days before the first dose of testosterone cypionate
- Receiving any other investigational agents or insufficient washout period of 4 weeks from prior investigational treatments
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, delayed wound healing, ulcers, bone fractures, or psychiatric/social conditions limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
A
Ashley Smith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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