Clinical trial · Interventional
Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer
Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed early due to poor recruitment
Summary
Brief summary (as posted)
RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial. PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well it works compared with surgery in treating patients with prostate cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Procedure | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm Rx1: Radical Prostatectomy
- description
- Arm Rx1: Radical Prostatectomy
- interventionNames
- Procedure: Radical Prostatectomy
- type
- OTHER
- label
- Arm Rx2: Brachytherapy
- description
- Arm Rx2: Brachytherapy
- interventionNames
- Procedure: Brachytherapy
Primary outcomes (2)
- measure
- Proportion of patients consenting to the treatment randomization
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS Meeting 1 of the following criteria: * Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2, Due for prostate biopsy or prostate biopsy performed in the last 6 weeks, PSA \< 15 ng/mL * Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test \< 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of \< 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA \> 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy \> 10 years (Decision-Aid Randomization) * Satisfactory results from biochemical and hematological profiles that, in the opinion of the investigator, does not preclude patient from the trial * No unacceptable risk for radical prostatectomy or prostate brachytherapy * INR \< 1.5 * No severe lower urinary tract symptoms * No significant obstructive urinary symptoms (i.e., peak urine flow rate \< 10 mL per second, and/or post micturition bladder volume \> 100 mL) * No other clinical or medical condition that, in the opinion of the investigator, precludes patient from taking part in the trial * No other active malignancy likely to interfere with subsequent protocol treatment and follow-up PRIOR CONCURRENT THERAPY: * No prior pelvic radiotherapy * No prior abdominoperineal (AP) rectal excision * No prior standard transurethral resection of prostate * No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens) * At least 5 days since prior aspirin or clopidogrel * No concurrent warfarin
References
Publications (1)
- RESULTEccles BK, Cross W, Rosario DJ, Doble A, Parker C, Logue J, Little L, Stanton L, Bottomley D. SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer. BJU Int. 2013 Aug;112(3):330-7. doi: 10.1111/bju.12127. PMID 23826842