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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 below
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I am older than 18 years.
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I have prostate cancer that is still contained within the prostate and requires radiation and hormone therapy.
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My prostate cancer was confirmed by MRI and biopsy.

BiolenRT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline versus 8 weeks post biolen implantation and 6 months post rt
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline versus 8 weeks post biolen implantation and 6 months post rt for reporting.

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

Bicalutamide (Anti-androgen agent) Clinical Trial Eligibility Overview. Trial Name: NCT04943536 — Phase 1
Prostate Adenocarcinoma Research Study Groups: Biolen+Radiation Therapy
Prostate Adenocarcinoma Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT04943536 — Phase 1
Bicalutamide (Anti-androgen agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04943536 — Phase 1
~2 spots leftby Oct 2024