Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
20Conditions
Prostate AdenocarcinomaDrugs
bicalutamideSummary
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.
Detailed Description
This study is a prospective, single-center, single-arm feasibility study. Up to 20 participants will be recruited to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate when delivered with radiotherapy.
At baseline, patients will undergo multiparametric MRI of the prostate. Study participants will have placement of the drug eluting Biolen implants. At the 8 week timepoint, participants will undergo repeat multiparametric MRI.
Participants will receive standard of care radiation therapy on weeks 9-11 and will be followed through 2 years post radiation. A third and fourth multiparametric MRI will be performed at 6 and 24 months after completion of radiation. Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits. Following completion of follow-up or removal from protocol, patients may be offered enrollment on long-term follow up protocols.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Deborah Citrin, MD
Principal Investigator
- Deborah Citrin, MD
Eligibility 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.
Study Plan
Biolen+Radiation Therapy
EXPERIMENTAL
Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
DRUG:
bicalutamideDescription:
localized anti-androgen therapyRADIATION:
Stereotactic body radiation therapyDescription:
localized radiation therapy
Outcome Measures
Primary Outcome Measures
Feasibility of replacing systemic androgen tx with targeted local delivery
Secondary Outcome Measures
Adverse Events
MRI changes
Biochemical progression free survival
Timeline
Last Updated
January 12, 2024Start Date
June 29, 2021Today
February 5, 2025Completion Date ( Estimated )
December 31, 2024
Sponsors of this trial
Lead Sponsor
Alessa Therapeutics Inc.Collaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years