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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
13,660 Previous Clinical Trials
40,924,252 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide details on other investigations that have utilized Stereotactic body radiation therapy?

"At present, 34 active clinical trials are currently investigating Stereotactic body radiation therapy with 14 of them in the final phase. Despite many being based out of Duarte, California, a total 3687 medical centres around the globe are running these studies."

Answered by AI

Is there an ongoing enrollment process for this trial?

"Affirmative. As per the data on clinicaltrials.gov, this experiment is still actively recruiting participants since its posting date of October 1st 2021 and recent update from the same month. This trial requires 20 individuals to be sourced from one medical centre."

Answered by AI

Has the FDA sanctioned Stereotactic body radiation therapy as an approved treatment?

"Assessed on a 1-3 scale, Stereotactic body radiation therapy has been judged as having minimal safety data with limited evidence of efficacy; it thus attained a score of 1."

Answered by AI

How many individuals are included in the current cohort of this research trial?

"Affirmative. According to the information presented on clinicaltrials.gov, this medical trial is actively enrolling participants at the moment. It was initially posted on October 1st 2021 and edited recently on the same date. The researchers are searching for 20 individuals from a single location."

Answered by AI

Is this research groundbreaking or has it been done before?

"Presently, 34 trials are underway for Stereotactic body radiation therapy across 849 cities in 27 countries. The inaugural trial took place back in 2000 under the aegis of AstraZeneca and included 600 patients in its Phase 3 drug approval process. In total, since that first study 74 further investigations have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
2021. "Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04943536.
~3 spots leftby Oct 2024
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