Clinical trial NCT06624813: Partial Prostatectomy for Prostate Cancer
Official title: Partial Robot-assisted Laparoscopic Prostatectomy for Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: partial prostatectomy in prostate cancer
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: This Phase 2 study aims to evaluate the feasibility and standardization of robotic partial prostatectomy in patients with localized intermediate-risk prostate cancer. The study will enroll 50 patients who have undergone prostate biopsies, categorized as Gleason grade group 2 or 3, with image-guided fusion at the Cancer Institute of the State of São Paulo. Eligible patients must also have a multiparametric prostate MRI (mpMRI) with a PIRADS score of 3 to 5, consistent with the biopsy laterality.

Surgeries will be performed at the Cancer Institute of the State of São Paulo by a high-volume robotic surgeon (Rafael Ferreira Coelho) using the da Vinci surgical system. Patients involved in this research will receive follow-up care in a specialized outpatient clinic, where multidisciplinary teams will administer questionnaires assessing urinary function, sexual function, perioperative pain, and quality of life, both preoperatively and postoperatively. Data will be collected in person and stored on the online REDCap® platform.

Postoperative complications will be classified and assessed using the Clavien-Dindo scale during the first 90 days following surgery. Oncological follow-up will include quarterly PSA tests in the first year, every four months in the second year, and semi-annually from the third year onward, continuing until the end of the five-year follow-up period. A new mpMRI and protocol biopsy of the remaining prostate lobe will be performed at the 6th and 12th month of follow-up, respectively.

Patients with negative biopsies for residual neoplasia will continue to be monitored with PSA. If residual neoplasia is detected, complementary treatment will be administered based on a shared decision-making process between the physician and the patient. This study will be conducted in compliance with Resolution 466/2012 of the National Health Council/Ministry of Health (CNS/MS) and the Declaration of Helsinki (2000), following approval from the Research Ethics Committee on Human Beings (CEPSH).

The study anticipates that patients treated under this protocol will achieve satisfactory oncological outcomes, with minimal impact on functional aspects such as urinary incontinence or sexual dysfunction, and low rates of postoperative complications or negative effects on quality of life.

Eligibility 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

Primary outcomes:
measure: Five-year postoperative retreatment-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: 3rd, 6th, 12th, 18th and 24th months
measure: American Urological Association Symptom Index - International Prostate Symptom Score (AUA-IPSS)
timeFrame: 3rd, 6th, 12th, 18th and 24th months
measure: Expanded Prostate Cancer Index Composite
timeFrame: 3rd, 6th, 12th, 18th and 24th months
measure: Quality of life: EuroQol-5D
timeFrame: 3rd, 6th, 12th, 18th and 24th months
measure: prostate specific antigen kinetics
timeFrame: 3rd, 6th, 12th, 18th, 24th, 30th, 36th, 42th, 48th, 54 and 60 months
measure: new magnetic resonance imaging per protocol at 6th month
timeFrame: 6th month
measure: new postoperative prostate biopsy on the residual prostatic lobe
timeFrame: 12th month
measure: Postoperative complications within 90 days of surgery
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Insituto do Câncer do Estado de São Paulo
Study officials:
References: