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Anti-androgen agent
Bicalutamide + Radiation Therapy for Prostate Cancer (BiolenRT Trial)
Phase 1
Recruiting
Led By Deborah Citrin, MD
Research Sponsored by Alessa Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years
Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline versus 8 weeks post biolen implantation and 6 months post rt
Awards & highlights
BiolenRT Trial Summary
This trial will test whether giving an anti-androgen agent locally to the prostate is just as effective as giving it systemically for treating prostate cancer.
Who is the study for?
Men over 18 with intermediate or high-risk localized prostate cancer suitable for radiation and anti-androgen therapy, but who refuse systemic ADT. They must have MRI-detected, biopsy-proven cancer and not used certain medications recently. Men with prior prostate cancer treatments or severe urinary symptoms are excluded.Check my eligibility
What is being tested?
The trial is testing the use of Bicalutamide implants (Biolen) combined with Stereotactic body radiation therapy as an alternative to standard Androgen Deprivation Therapy in treating localized prostate cancer.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with anti-androgens like hot flashes, breast tenderness/enlargement, and sexual dysfunction; plus typical risks from radiation such as skin irritation, fatigue, and urinary issues.
BiolenRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have prostate cancer that is still contained within the prostate and requires radiation and hormone therapy.
Select...
My prostate cancer was confirmed by MRI and biopsy.
BiolenRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline versus 8 weeks post biolen implantation and 6 months post rt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline versus 8 weeks post biolen implantation and 6 months post rt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of replacing systemic androgen tx with targeted local delivery
Secondary outcome measures
Adverse Events
Biochemical progression free survival
MRI changes
BiolenRT Trial Design
1Treatment groups
Experimental Treatment
Group I: Biolen+Radiation TherapyExperimental Treatment2 Interventions
Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
FDA approved
Stereotactic body radiation therapy
2017
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Alessa Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
37 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,718 Previous Clinical Trials
40,963,324 Total Patients Enrolled
Deborah Citrin, MDPrincipal InvestigatorNational Cancer Institute (NCI)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have intermediate or high-risk prostate cancer and refuse hormone therapy.I am older than 18 years.I haven't used medications like Finasteride or Dutasteride for more than 3 months in the last 2 years.I have prostate cancer that is still contained within the prostate and requires radiation and hormone therapy.My prostate cancer was confirmed by MRI and biopsy.I am at high risk and open to hormone therapy for my cancer.I cannot have an MRI due to a medical device I have or another reason.My prostate was larger than 80 cc on my last MRI.My prostate symptoms are severe.I have had radiotherapy or surgery for prostate cancer.I am currently on or have had hormone therapy for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Biolen+Radiation Therapy
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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