Stereotactic body radiation therapy for Prostate Adenocarcinoma

Phase-Based Progress Estimates
National Cancer Institute, Bethesda, MDProstate AdenocarcinomaStereotactic body radiation therapy - Radiation
What conditions do you have?

Study 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.

Eligible Conditions
  • Prostate Adenocarcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: baseline versus 8 weeks post biolen implantation and 6 months post RT

24 months post RT
Biochemical progression free survival
27 months
Feasibility of replacing systemic androgen tx with targeted local delivery
Month 6
MRI changes
through 27 months
Adverse Events

Trial Safety

Trial Design

1 Treatment Group

Biolen+Radiation Therapy
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic body radiation therapy · No Placebo Group · Phase 1

Biolen+Radiation TherapyExperimental Group · 2 Interventions: Stereotactic body radiation therapy, bicalutamide · Intervention Types: Radiation, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic body radiation therapy
Completed Phase 1
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline versus 8 weeks post biolen implantation and 6 months post rt

Who is running the clinical trial?

Alessa Therapeutics Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,288 Total Patients Enrolled
Deborah Citrin, MDPrincipal InvestigatorNational Cancer Institute (NCI)

Eligibility Criteria

Age 18+ · Male Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Is there an ongoing enrollment process for this trial?

"Affirmative. As per the data on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"Affirmative. According to the information presented on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.