Clinical trial · Interventional
Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer
NCT02911922CI-TRIAL-00038357terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of patient accruals.
Summary
Brief summary (as posted)
Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endorectal Balloon | Device | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Rectal Spacer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endorectal balloon - Radiation therapy
- description
- Group 1 : Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.
- interventionNames
- Device: Endorectal Balloon
- Radiation: Radiation therapy
- type
- EXPERIMENTAL
- label
- Rectal spacer - Radiation therapy
- description
- Group 2 : Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months. Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven diagnosis of prostate adenocarcinoma, diagnosed within 1 year of randomization * Either NCCN-defined low-risk disease (T1c-T2a, Gleason score 3+3=6, PSA \<10), intermediate-risk disease (Gleason score 3+4=7, 4+3=7, T2b-c and/or PSA 10-20; ) or high-risk disease due to Gleason score 8-10 and/or PSA \>20 ng/ml, but not due to T3-T4 disease on physical exam. Exclusion Criteria: * History of prior pelvic radiation (external beam or brachytherapy) * Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years * Very high risk prostate cancer (T3b-T4 on clinical exam, Primary Gleason pattern 5, or \>4 cores with Gleason score 8-10) * History of prior chemotherapy for prostate cancer * History of irritable bowel disease * Evidence of lymph node involvement * AUA score \>15 * Prostate size \> 90 cc
References
Publications (0)
Data not yet available
No reference posted for this study.