CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 12 target
Drug / intervention
Stereotactic Body Radiation Therapy (SBRT)radiation
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically proven adenocarcinoma of the prostate
  • ✓T1-2b stage (AJCC 7th edition)
  • ✓Gleason score 6 or 7 (3+4) or Gleason 7 (4+3) with PSA <10
  • ✓PSA under 15 ng/dL or Gleason 7(4+3) with PSA <10
Key exclusion· 17
  • ✕Opting for another treatment modality such as surgery or active surveillance
  • ✕Prior or concurrent invasive malignancy except non-melanomatous skin cancer unless disease-free for minimum 5 years
  • ✕Carcinoma of the bladder including in situ or superficial bladder cancer
  • ✕Evidence of distant metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04004312
NCT04004312N/ARecruitingOn TrackUpdated 12mo ago
Long Recruiting
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Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

Fabio Cury·interventional·Posted Jul 2, 2019·Updated Jun 25, 2025

In Brief

A clinical study evaluating Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer. Currently recruiting, targeting 12 participants across 1 site.

Detailed Summary

It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment. Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada
CollaboratorsBoston Scientific Corporation

Timeline

N/ARecruiting
2019202020212022202320242025202620272028
First PostedJul 2, 2019
Enrollment StartNov 7, 2018
Primary CompletionJan 31, 2027
Study CompletionDec 20, 2027
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 7 years agoPrimary completion in 7 months

Interventions

Stereotactic Body Radiation Therapy (SBRT)radiation

Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.