Combination Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJingsong Zhang, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for men with high-risk, stage IV prostate cancer who haven't had extensive prior treatments. They should be relatively healthy (ECOG 0-1), have not used certain hormone therapies recently, and must agree to use contraception. Men with uncontrolled heart issues, recent investigational drugs, brain metastases, or autoimmune diseases are excluded.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through a biopsy.

I am fully active or can carry out light work.

My prostate cancer is high risk with a Gleason score of 8+, 3+ bone metastases, or visceral metastasis.

+9 more

Exclusion Criteria

I have a history of lung conditions like interstitial lung disease or pulmonary fibrosis.

History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

I have had surgery to remove my prostate.

+15 more

Participant Groups

The study tests if starting treatment with hormonal therapy (LHRH analog plus a new agent like abiraterone) followed by chemotherapy (docetaxel) improves outcomes in advanced prostate cancer. Participants will first receive the hormonal therapy then move on to chemohormonal therapy.

1Treatment groups

Experimental Treatment

Group I: First Strike then Second StrikeExperimental Treatment4 Interventions

The first part of the study treatment or "first strike" involves 12-18 weeks of combined therapy with LHRH analog and one of the new hormonal agents (NHAs). Participants will complete the "first strike" at week 13 if their PSA has reduced \>90%; otherwise they will complete a total of 18 weeks of therapy. The second part of the treatment or "second strike" involves 4 cycles docetaxel and LHRH analog. The "second strike" will start immediately after the "first strike". MRI guided prostate biopsy will be performed after "second strike". For patients with positive prostate biopsy or detectable PSA, the "second strike" will be consolidated with 4-6 additional cycles of docetaxel plus 6 doses of tislelizumab at 200 mg, given IV once every 3 weeks. For patients with undetectable PSA at year 3 from study enrollment, LHRH analog can be discontinued.