NCT04943536Active, not recruitingPhase 1
Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 15 Jun 2021
- Start date
- 7 Dec 2021
- Primary completion date
- 24 Apr 2027
- Lead sponsor
- Alessa Therapeutics Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT04943536
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 7 Dec 2021 to the primary completion date, 24 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
Other
- International Prostate Symptom Score ≥ 20.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.