Clinical trial · Interventional
A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer
Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
NCT05027477CI-TRIAL-00093754CAPTAINactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.
Conditions
Conditions (2)
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical Prostatectomy | Device | — | UNRESOLVED |
| TULSA Procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radical Prostatectomy
- description
- Patients in this group will undergo Radical prostatectomy. There will be about 67 people in this group.
- interventionNames
- Device: Radical Prostatectomy
- type
- EXPERIMENTAL
- label
- TULSA Procedure
- description
- Patients in this group will undergo TULSA Procedure. There will be about 134 people in this group.
- interventionNames
- Device: TULSA Procedure
Primary outcomes (2)
- measure
- Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Age 40 to 80 years, with \>10 years life expectancy * NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months * Stage ≤cT2c, N0, M0 * ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy * PSA ≤20ng/mL within last 3 months * Treatment-naïve * Planned ablation volume is \< 3 cm axial radius from urethra on mpMRI acquired within last 6 months Exclusion Criteria: * Inability to undergo MRI or general anesthesia * Suspected tumor is \> 30 mm from the prostatic urethra * Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor * Unresolved urinary tract infection or prostatitis * History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder * Artificial urinary sphincter, penile implant, or intraprostatic implant * Patients who are otherwise not deemed candidates for radical prostatectomy * Inability or unwillingness to provide informed consent * History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
References
Publications (0)
Data not yet available
No reference posted for this study.