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Partial Prostatectomy for Prostate Cancer
RECRUITINGN/ASponsored by Instituto do Cancer do Estado de São Paulo
Actively Recruiting
PhaseN/A
SponsorInstituto do Cancer do Estado de São Paulo
Started2024-04-01
Est. completion2025-12
Eligibility
Age40 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06624813
Summary
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).
Eligibility
Age: 40 Years – 80 YearsSex: MALEHealthy volunteers accepted
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
Conditions2
CancerProstate Cancer
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Actively Recruiting
PhaseN/A
SponsorInstituto do Cancer do Estado de São Paulo
Started2024-04-01
Est. completion2025-12
Eligibility
Age40 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06624813