A Study of Leuprolide to Treat Prostate Cancer

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Abbott

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.

Research Team

Kristof Chwalisz, MD, PhD

Principal Investigator

Abbott

Eligibility Criteria

Inclusion Criteria

Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment.

Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.

Life expectancy of at least 18 months.

Treatment Details

Interventions

• Leuprolide acetate - Formulation A (Hormone Therapy)
• Leuprolide acetate - Formulation B (Hormone Therapy)

Participant Groups

Group I: Leuprolide acetate - Formulation B Experimental Treatment 1 Intervention

Leuprolide acetate, 45 mg, 6-month depot

Group II: Leuprolide acetate - Formulation A Experimental Treatment 1 Intervention

Leuprolide acetate 45 mg, 6-month depot

Who Is Running the Clinical Trial?

Abbott

Lead Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business