NCT05189457 - First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 25, 2022

Primary Completion Date

July 15, 2027

Study Completion Date

July 31, 2028

Conditions

Prostate CancerStage IV Prostate Cancer

Interventions

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.

Trial Locations (1)

33612

Moffitt Cancer Center, Tampa