Study Summary
This trial tests whether rectal spacer hydrogel can reduce radiation dose to the rectum in patients with prostate cancer.
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Baseline and up to 2 years post-treatment
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Nehlsen, Anthony D., Kunal K. Sindhu, Erin Moshier, John P. Sfakianos, and Richard G. Stock. 2021. “The Impact of a Rectal Hydrogel Spacer on Dosimetric and Toxicity Outcomes Among Patients Undergoing Combination Therapy with External Beam Radiotherapy and Low-dose-rate Brachytherapy”. Brachytherapy. Elsevier BV. doi:10.1016/j.brachy.2020.09.018.
- Richard.G. Stock 2021. "Rectal Spacer Hydrogel Before Radiation Therapy in Reducing Radiation Dose to the Rectum in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05224869.
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 clinicaltrials.gov" - Anonymous Online Contributor
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
How many people are receiving treatment as part of this experiment?
"That is correct, the online information on clinicaltrials.gov 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