Clinical trial · Interventional
Partial Prostatectomy for Prostate Cancer
Partial Robot-assisted Laparoscopic Prostatectomy for Intermediate Risk Prostate Cancer
NCT06624813CI-TRIAL-00081275P-RALPunknownN/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)
A phase 2 study investigation of safety and feasibility of partial prostatectomy for localized prostate cancer of intermediate risk at ICESP. It will be included 50 patients that have coincident findings of prostate cancer site on prostate biopsy and a suspicious area in the magnetic resonance imaging of the prostate (PIRADS 3, 4 or 5).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot-assisted partial prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Partial prostatectomy
- description
- Robot-assisted partial prostatectomy in patients with prostate cancer
- interventionNames
- Procedure: Robot-assisted partial prostatectomy
Primary outcomes (1)
- measure
- Five-year postoperative retreatment-free survival
- timeFrame
- 5 years
- description
- Rate of patients who are free from additional treatment for the reminiscent prostatic lobe
Secondary outcomes (8)
- measure
- Sexual Health Inventory for Men (SHIM)
- timeFrame
- 3rd, 6th, 12th, 18th and 24th months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Patients with prostate cancer that presents an institutional (ICESP) fusion biopsy (cognitive or target) that presents 1. Fusion-guided prostate biopsy with mpMRI performed at the São Paulo State Cancer Institute, which 2. Present fragments for ISUP group grade (GG) ≤ 3 in only one of the prostate lobes 3. Multiparametric prostate resonance with PIRADS 3 - 5 and which is in agreement with the laterality of the tumor in the prostate biopsy 4. Life expectancy ≥ 10 years according to the Charlson score 5. Absence of second primary cancer under active treatment. Patients treated for cancer from other sites for more than 5 years and without evidence of disease will be allowed 6. Able to read, understand and complete the informed consent related to the research, as well as the research questionnaires on quality of life and functional parameters on erection and urinary continence Exclusion Criteria: 1. Patients with prostate cancer with an histology different from adenocarcinoma 2. Suspicion of lymph node metastasis on mpMRI or distant bone scintigraphy 3. definitive signs of extraprostatic extension on mpMRI 4. history of pelvic/prostatic radiotherapy 5. ISUP grade group ≥ 4 6. Laterality of prostate biopsy discordant with mpMRI findings
References
Publications (0)
Data not yet available
No reference posted for this study.