Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Pros… (NCT07766486) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy
Italy30 participantsStarted 2019-09-26
Plain-language 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.
Who can participate
Age range
41 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Aspartate aminotransferase less than 2.5 times the upper limit of normal.
* Alanine aminotransferase less than 2.5 times the upper limit of normal.
* Total bilirubin no more than 1.5 times the upper limit of normal, except in participants with documented Gilbert syndrome.
* Available and willing to attend all protocol-specified follow-up visits.
Exclusion Criteria:
* Special histological subtypes of prostate car…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: From the date of radical prostatectomy until death from any cause, assessed up to 5 years after radical prostatectomy.
2
Progression-Free Survival
Timeframe: 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.