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

NCT05189457 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	32
Start date	2022-01-25
Completion	2028-07

Conditions

• Prostate Cancer
• Stage IV Prostate Cancer

Interventions

• Luteinizing Hormone Releasing Hormone
• New Hormonal Agent
• Docetaxel
• Tislelizumab

Primary outcomes

• Overall Survival — Up to 36 months
  Overall survival will be from initiation of first strike until failure or death from any cause.

Countries

United States