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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07476001
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testosterone cypionate (Tc) — DRUG
    IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
  • ADT with Luteinizing hormone-releasing hormone (LHRH) analog — DRUG
    Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.
  • PSMA-617 — DRUG
    IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.

Study Details

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.

Key Dates

Start date
Mar 3, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm: Tc400 followed by PSMA-617 (with continued ADT)
    Participants will receive Tc400 followed by PSMA-617, while continuing standard of care androgen deprivation therapy.

Primary Outcome Measure

Feasibility of Tc400 and PSMA-617 [ Time Frame: Up To 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Jingsong Zhang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Juskaran Chadha, DO (SUB_INVESTIGATOR)
Jon Chatzkel, MD (SUB_INVESTIGATOR)
Ghazal (Gigi) Jameel, APRN (SUB_INVESTIGATOR)
Angel Johnson, APRN (SUB_INVESTIGATOR)
Tianshi (Mike) Liu, MD (SUB_INVESTIGATOR)
Sarah Mizelle, PA-C (SUB_INVESTIGATOR)
Aakash Patel, MD (SUB_INVESTIGATOR)
Aditi Patel, PA-C (SUB_INVESTIGATOR)
Alyssa Thompson, APRN (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Moffitt Cancer Center· Tampa, FL

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