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Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy

NCT07766486 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-14

No results posted yet for this study

Summary

MAZINGA is a prospective, single-group pilot study evaluating disease control after robot-assisted radical prostatectomy with extended pelvic lymph-node dissection in men with oligometastatic hormone-sensitive prostate adenocarcinoma who have received androgen-deprivation therapy for at least 6 months and achieved a serum prostate-specific antigen (PSA) level below 4 ng/mL. Eligible participants have no more than five bone metastases confined to the spine and/or pelvis, no visceral or retroperitoneal lymph-node metastases, and no bulky pelvic lymph nodes.

All participants undergo surgery and continue androgen-deprivation therapy as prescribed by their treating oncologist. PSA and serum testosterone are assessed for 24 months. Contrast-enhanced computed tomography plus whole-body bone scintigraphy, or prostate-specific membrane antigen positron emission tomography according to the imaging approach used at staging and clinical judgment, is performed every 6 months. The study evaluates overall survival, progression-free survival, pathological and PSA responses, quality of life, serum biomarkers, urinary complications, and conversion to open surgery.

Conditions

  • Oligometastatic Hormone-Sensitive Prostate Cancer
  • Prostate Adenocarcinoma

Interventions

PROCEDURE

Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection

Robot-assisted laparoscopic radical prostatectomy is performed under general anaesthesia and is preceded by a modified extended bilateral pelvic lymphadenectomy including the iliac-obturator and presacral regions. The procedure is performed with the Da Vinci robotic surgical system. Ongoing androgen-deprivation therapy is managed by the treating oncologist

Sponsors & Collaborators

  • Fondazione del Piemonte per l'Oncologia

    lead OTHER

Principal Investigators

  • Francesco Porpiglia, MD · FPO-IRCCS Cancer Institute of Candiolo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
41 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2025-04-23
Completion
2030-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766486 on ClinicalTrials.gov