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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: Tc400 followed by PSMA-617 (with continued ADT) | Experimental | Participants will receive Tc400 followed by PSMA-617, while continuing standard of care androgen deprivation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone cypionate (Tc) | Drug | IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Tc400 and PSMA-617 | Percentage of patients who can complete 3 doses of Tc400 followed by at least 2 doses of PSMA-617. | Up To 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in P/T ratio | Percentage of evaluable patients with 50% reduction in P/T ratio (PT50) compared to baseline P/T ratio based on PSA and testosterone values at screening. | Up To 6 Months |
| PSA50 and PSA 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Smith | Contact | 813-745-2937 | Ashley.Smith@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Jingsong Zhang, MD, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| 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. |
|
Percentage of patients who achieved PSA50 and PSA 90 responses after two doses of PSMA-617 compared to the pre PSMA-617 PSA values at day 60.
| Up To 6 Months |
| ID | Term |
|---|---|
| C016131 | testosterone 17 beta-cypionate |
| D000726 | Androgen Antagonists |
| D007987 | Gonadotropin-Releasing Hormone |
| C000602389 | PSMA-617 |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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