Robotic partial prostatectomy for localized prostate cancer
Partial Robot-assisted Laparoscopic Prostatectomy for Intermediate Risk Prostate Cancer
This study is testing if robotic surgery to remove part of the prostate is safe and effective for men with localized intermediate-risk prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06624813 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of robotic partial prostatectomy in patients with localized intermediate-risk prostate cancer. It will enroll 50 patients who have undergone prostate biopsies and have a corresponding suspicious area identified in their multiparametric MRI. Surgeries will be performed by an experienced robotic surgeon, and patients will receive comprehensive follow-up care to assess their urinary and sexual function, pain levels, and overall quality of life. Data will be collected and analyzed to evaluate the outcomes of the procedure over a five-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates are men with localized intermediate-risk prostate cancer who have specific imaging and biopsy findings consistent with the study criteria.
Not a fit: Patients with prostate cancer histology other than adenocarcinoma or those with a second primary cancer under active treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive surgical option for patients with localized prostate cancer, potentially leading to improved recovery and quality of life.
How similar studies have performed: While robotic partial prostatectomy is a well-established procedure, this specific approach for intermediate-risk localized prostate cancer is being evaluated for its feasibility and safety, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
São Paulo
- Insituto do Câncer do Estado de São Paulo — São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.