Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Running, not enrolling · Phase 1
Conditions studied: Prostate Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT04943536
- Run by
- Alessa Therapeutics Inc.
- People needed
- 20
- Starts
- 2021-12-07
- Expected to finish
- 2027-08-15
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR
- NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR
- NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) > 20 AND refuses to receive systemic ADT.
- Age >18 years.
You may not qualify if…
- 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.
Where it is running
- National Cancer Institute — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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