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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

NCT07476001 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-15

No results posted yet for this study

Summary

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

Interventions

DRUG

Testosterone cypionate (Tc)

IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.

DRUG

ADT with Luteinizing hormone-releasing hormone (LHRH) analog

Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.

DRUG

PSMA-617

IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jingsong Zhang, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2027-09-30
Completion
2027-09-30
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 NCT07476001 on ClinicalTrials.gov