NCT05189457

First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer

A Phase IIA Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for High Risk Metastatic Castration Sensitive Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) followed by chemohormonal therapy with docetaxel and LHRH analog would improve the outcome of high risk metastatic/stage IV prostate cancer.

Conditions

• Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Luteinizing Hormone Releasing Hormone	During the first strike, LHRH will be administered for 12 to 18 weeks. During the second strike, participants will receive 4 cycles of LHRH
DRUG	New Hormonal Agent	During the first strike, if Abiraterone is chosen 1000mg of Abiraterone will be taken orally. If Enzalutamide is used, 160 mg will be taken orally every 24 hours.
DRUG	Docetaxel	During the second strike, participants will receive 4 cycles of Docetaxel at 75mg/m2 given intravenously at day 1 of ever 21 days. For participants with positive prostate biopsy or detectable PSA, the "second strike" will receive 2 additional cycles of docetaxel.
DRUG	Tislelizumab	During the second strike, participants will receive 6 doses of Tislelizumab at 200 mg, given intravenously once every 3 weeks.

Timeline

• Start date: 2022-01-25
• Primary completion: 2027-07-15
• Completion: 2028-07-01
• First posted: 2022-01-12
• Last updated: 2025-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study