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

NCT07766486 | Active Not Recruiting DMC

• 1 other identifier: 017-FPO19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prostate Adenocarcinoma; oligometastatic prostate cancer; hormone-sensitive prostate cancer; cytoreductive radical prostatectomy; robot-assisted radical prostatectomy; androgen-deprivation therapy; extended pelvic lymph-node dissection; PSMA PET

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Overall survival is defined as the time from the date of radical prostatectomy to death from any cause. Participants who are alive at the time of analysis will be censored at the last date on which they were known to be alive

  From the date of radical prostatectomy until death from any cause, assessed up to 5 years after radical prostatectomy.

• Progression-Free Survival

  Time from radical prostatectomy to radiological disease progression or death in the absence of documented progression. Radiological progression will be assessed according to the protocol-defined imaging criteria.

  From the date of radical prostatectomy until the first documented radiological disease progression or death from any cause, whichever occurs first, assessed up to 24 months after radical prostatectomy.

Secondary Outcomes (10)

• Expanded Prostate Cancer Index Composite for Clinical Practice Total and Domain Scores

  At 3 months and 12 months after radical prostatectomy.

• International Prostate Symptom Score Total Score

  At 3 months and 12 months after radical prostatectomy.

• Pathological Complete Response Rate

  At radical prostatectomy (Day 0)

• PSA Response Rate

  From the baseline sample to From the baseline sample to 5 years from last prostatectomy

• Serum Testosterone Concentration

  Screening and 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after radical prostatectomy

Study Arms (1)

Arm 1: Radical Prostatectomy Plus Ongoing Androgen-Deprivation Therapy

EXPERIMENTAL

Participants who have received at least 6 months of androgen-deprivation therapy and achieved a PSA level below 4 ng/mL undergo robot-assisted laparoscopic radical prostatectomy with modified extended bilateral pelvic lymph-node dissection. Androgen-deprivation therapy is continued according to the treating oncologist

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

Interventions

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

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

Arm 1: Radical Prostatectomy Plus Ongoing Androgen-Deprivation Therapy

Eligibility Criteria

• Age: 41 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and consent for the use of personal data.
• Male sex and age greater than 40 years.
• Histologically or cytologically confirmed acinar adenocarcinoma of the prostate.
• Oligometastatic bone disease with no more than 5 metastatic bone lesions, none located outside the spine or pelvis. \[Confirm the intended threshold because the protocol also states \<5.\]
• No retroperitoneal lymph-node metastases and no visceral metastases.
• No bulky pelvic lymph-node metastases greater than 3 cm.
• Eligible for radical prostatectomy and lymphadenectomy.
• Eastern Cooperative Oncology Group performance status 0 or 1.
• Life expectancy of at least 1 year.
• Receiving androgen-deprivation therapy for at least 6 months.
• Serum PSA below 4 ng/mL after at least 6 months of androgen-deprivation therapy.
• White blood cell count at least 3,000/mm³ and/or absolute granulocyte count at least 1,000/mm³.
• Platelet count at least 100,000/mm³.
• Haemoglobin at least 10 g/dL.
• Serum creatinine no more than 1.5 times the upper limit of normal.

You may not qualify if:

• Special histological subtypes of prostate carcinoma
• PSA greater than 100 ng/mL at diagnosis before starting androgen-deprivation therapy.
• Visceral metastases or retroperitoneal lymph-node metastases.
• Pelvic lymph-node metastases greater than 3 cm.
• More than 5 metastatic bone lesions or bone metastases outside the spine or pelvis.
• Concomitant treatment with other antineoplastic agents, including investigational endocrine therapies.
• Hypogonadism or severe androgen deficiency defined as serum testosterone below 100 ng/dL.
• History of pituitary or adrenal insufficiency.
• Concomitant or planned treatment with medicines that affect androgen metabolism, including spironolactone, ketoconazole, finasteride or dutasteride.
• Active malignancy or malignancy diagnosed within the previous 5 years, except basal-cell carcinoma of the skin.
• Uncontrolled arterial hypertension, defined as systolic blood pressure at least 160 mmHg or diastolic blood pressure at least 95 mmHg. Participants with a history of hypertension are eligible if blood pressure is controlled with antihypertensive treatment.
• Severe uncontrolled concomitant disease or medical condition, including active uncontrolled infection.
• Clinically significant cardiovascular disease, including myocardial infarction or an arterial thrombotic event within the previous 6 months, severe or unstable angina, symptomatic cardiac arrhythmia or arrhythmia requiring treatment, recent deep-vein thrombosis, pulmonary embolism, cerebrovascular event or ischaemic event.
• Acute or chronic hepatitis.
• Dementia or psychiatric illness that limits compliance with study requirements or may prevent understanding or signing the informed-consent form.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Direzione di Chirurgia Urologica, INOC, viale della Ricerca 7, 10060 Candiolo, Turin 10060

Candiolo, Torino (TO), 10060, Italy

Location

Study Officials

• Francesco Porpiglia, MD

  FPO-IRCCS Cancer Institute of Candiolo

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All eligible participants undergo robot-assisted radical prostatectomy with extended pelvic lymph-node dissection while continuing androgen-deprivation therapy.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 14, 2026
• Study Start: September 26, 2019
• Primary Completion: April 23, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)