Partial Prostatectomy for Prostate Cancer

NCT06624813 | Recruiting DMC

• 2 other identifiers: ICESP (CCEP ICESP 4017/23)BRAZILIAN MINISTRY OF HEALTH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Keywords

partial prostatectomy in prostate cancer

Outcome Measures

Primary Outcomes (1)

• Five-year postoperative retreatment-free survival

  Rate of patients who are free from additional treatment for the reminiscent prostatic lobe

  5 years

Secondary Outcomes (8)

• Sexual Health Inventory for Men (SHIM)

  3rd, 6th, 12th, 18th and 24th months

• American Urological Association Symptom Index - International Prostate Symptom Score (AUA-IPSS)

  3rd, 6th, 12th, 18th and 24th months

• Expanded Prostate Cancer Index Composite

  3rd, 6th, 12th, 18th and 24th months

• Quality of life: EuroQol-5D

  3rd, 6th, 12th, 18th and 24th months

• prostate specific antigen kinetics

  3rd, 6th, 12th, 18th, 24th, 30th, 36th, 42th, 48th, 54 and 60 months

Study Arms (1)

Partial prostatectomy

EXPERIMENTAL

Robot-assisted partial prostatectomy in patients with prostate cancer

Procedure: Robot-assisted partial prostatectomy

Interventions

Robot-assisted partial prostatectomy PROCEDURE

Focal therapy with surgery for single lobe prostate cancer, partial robot-assisted partial prostatectomy

Also known as: Robot-assisted partial prostatectomy in patients with prostate cancer

Partial prostatectomy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate cancer that presents an institutional (ICESP) fusion biopsy (cognitive or target) that presents
• Fusion-guided prostate biopsy with mpMRI performed at the São Paulo State Cancer Institute, which
• Present fragments for ISUP group grade (GG) ≤ 3 in only one of the prostate lobes
• Multiparametric prostate resonance with PIRADS 3 - 5 and which is in agreement with the laterality of the tumor in the prostate biopsy
• Life expectancy ≥ 10 years according to the Charlson score
• 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
• 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

You may not qualify if:

• Patients with prostate cancer with an histology different from adenocarcinoma
• Suspicion of lymph node metastasis on mpMRI or distant bone scintigraphy
• definitive signs of extraprostatic extension on mpMRI
• history of pelvic/prostatic radiotherapy
• ISUP grade group ≥ 4
• Laterality of prostate biopsy discordant with mpMRI findings

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Insituto do Câncer do Estado de São Paulo

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: October 3, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-03

Locations

BR (1)