Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is indicated for the treatment of localized prostate cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alessa Therapeutics Inc.
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bicalutamide

Criteria

Inclusion Criteria:

• Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer)

• Patients must have at least 1 MRI detected; biopsy proven prostate cancer.

• Patients diagnosed as one of the following:

1. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR

2. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR

3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) > 20 AND refuses to receive systemic ADT.

• Age >18 years.

Exclusion Criteria:

• NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT.

• Patients receiving prior radiotherapy or surgery for prostate cancer.

• Patients receiving prior or ongoing ADT.

• Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.

• Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of > 3 months.

• Prostate volume more than 80 cc at prior MRI imaging.

• International Prostate Symptom Score ≥ 20.