Study Comparing Darolutamide with Androgen Deprivation Therapy (ADT) to ADT Alone in Men with Hormone Sensitive Prostate Cancer and Rising PSA Levels After Local Treatments

Sponsor: Bayer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05794906

Provider View

This clinical trial is exploring whether adding the drug darolutamide to standard hormone therapy (ADT) can help men with prostate cancer that has returned, as indicated by rising PSA levels, live longer without their cancer worsening compared to ADT alone.

Patient Parameters

Program Overview

Researchers are investigating a new treatment approach for men whose prostate cancer has returned after surgery or radiation, as shown by rising PSA levels. PSA is a protein that indicates prostate cancer activity. Even if scans don't show cancer, a rise in PSA can mean the cancer is back. This study will compare the effects of darolutamide combined with hormone therapy (ADT) against ADT alone to see if it helps patients live longer without their cancer getting worse.

Description

The study aims to find out if combining darolutamide with ADT can extend the time men live without their prostate cancer worsening, compared to ADT alone. Participants will be randomly assigned to receive either darolutamide plus ADT or a placebo plus ADT for 24 months, unless their cancer progresses or they experience medical issues. The study includes a screening phase, treatment phase, and follow-up phase. Participants will undergo various tests, including blood and urine samples, PSA and testosterone level checks, physical exams, heart health assessments, and imaging scans. The study will also allow for image-guided radiotherapy or surgery if needed. Participants' health and cancer status will be monitored throughout the study and for 30 days after the last treatment.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent and follow study requirements.
  • Male, 18 years or older.
  • Confirmed prostate cancer diagnosis.
  • Previously treated with surgery and/or radiation.
  • High-risk biochemical recurrence, defined by specific PSA levels and doubling time.
  • Must undergo a PSMA PET/CT scan during screening.
  • Sufficient testosterone levels.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood counts and organ function.
  • Agree to use contraception during treatment and for at least 1 week after the last dose.

Exclusion Criteria

  • Certain types of prostate cancer, such as small cell or neuroendocrine carcinoma.
  • History of testicle removal surgery.
  • Cancer spread to certain areas as shown by scans.
  • Brain metastasis detected by PSMA PET/CT.
  • High-risk recurrence after primary radiotherapy with new lesions eligible for surgery.
  • Previous treatment with certain prostate cancer drugs within 18 months.
  • Previous PSMA-radiotherapeutics treatment within 12 months.
  • Recent radiotherapy within 8 weeks.
  • Other cancers within the last 5 years, except for certain skin or bladder cancers.
  • History of pelvic radiotherapy for other cancers.

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