Stereotactic body radiation therapy for Prostate Cancer

Phase-Based Progress Estimates
Mount Sinai Hospital, New York, NYProstate CancerStereotactic body radiation therapy - Procedure
What conditions do you have?

Study Summary

This trial tests whether rectal spacer hydrogel can reduce radiation dose to the rectum in patients with prostate cancer.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline and up to 2 years post-treatment

Month 2
The proportion of participants that achieve V100rectum < 0.75 cc
Month 3
Month 2
Number of participants with radiographic distortion
Year 2
Change in Expanded Prostate Cancer Index Composite (EPIC)
Change in International Prostate Symptom Score (IPSS)
Change in Sexual Health Index in Men (SHIM)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Patients with prostate cancer
1 of 1

Experimental Treatment

57 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic body radiation therapy · No Placebo Group · Phase 2

Patients with prostate cancerExperimental Group · 5 Interventions: CT simulation, Stereotactic body radiation therapy, Post-implant dosimetry scan, Medical Device Usage and Evaluation, Brachytherapy · Intervention Types: Procedure, Procedure, Procedure, Device, Radiation
First Studied
Drug Approval Stage
How many patients have taken this drug
CT simulation
Stereotactic body radiation therapy
Completed Phase 1
Medical Device Usage and Evaluation
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and up to 2 years post-treatment

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
790 Previous Clinical Trials
508,902 Total Patients Enrolled
11 Trials studying Prostate Cancer
38,258 Patients Enrolled for Prostate Cancer
Richard StockPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You're healthy enough to receive rectal spacer placement, external beam radiotherapy and brachytherapy as determined by your doctors.

Frequently Asked Questions

Can patients join this trial at the current moment?

"Yes, this trial is recruiting patients as of now. The first posting was on 8/3/2021, with the most recent update happening on 1/25/2022 according to" - Anonymous Online Contributor

Unverified Answer

Does Stereotactic body radiation therapy carry any risks for patients?

"While there is some evidence of safety, as this is a Phase 2 trial, none of the data collected thus far supports efficacy. Therefore, our team has given Stereotactic body radiation therapy a score of 2." - Anonymous Online Contributor

Unverified Answer

How many people are receiving treatment as part of this experiment?

"That is correct, the online information on shows that this study needs more participants and is currently open for enrolment. This trial was first advertised on August 3rd 2021 and was updated most recently on January 25th 2022. So far, 57 patients have been recruited from 1 location." - 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.