Oligometastatic Hormone-Sensitive Prostate CancerMAZINGANCT07766486
Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy
A study testing Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection in people with Oligometastatic Hormone-Sensitive Prostate Cancer and Prostate Adenocarcinoma, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 41 years and older, men only
- Conditions the study is for
- Oligometastatic Hormone-Sensitive Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2019to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Previous finasteride or dutasteride treatment discontinued less than 6 months before enrolment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Direzione di Chirurgia Urologica, INOC, viale della Ricerca 7, 10060 Candiolo, Turin 10060
Candiolo, Torino (TO), 10060
About this study
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.
Read the detailed description
Radical prostatectomy is being investigated as a cytoreductive treatment in selected men with oligometastatic hormone-sensitive prostate cancer who respond to androgen-deprivation therapy (ADT). MAZINGA is a prospective, single-centre, single-group pilot study designed to obtain preliminary estimates of survival and treatment response after the addition of radical prostatectomy to ongoing ADT.
Eligible participants have acinar prostate adenocarcinoma, no more than five bone metastases confined to the spine and/or pelvis, no visceral or retroperitoneal nodal metastases, no bulky pelvic nodes greater than 3 cm, an Eastern Cooperative Oncology Group performance status of 0 or 1, and a PSA level below 4 ng/mL after at least 6 months of ADT. Participants undergo robot-assisted laparoscopic radical prostatectomy with modified extended bilateral pelvic lymph-node dissection. ADT is continued according to the treating oncologist.
PSA and serum testosterone are measured at months 1 and 3 and every 3 months thereafter through month 24. Contrast-enhanced computed tomography of the chest and abdomen plus whole-body bone scintigraphy are performed every 6 months through month 24; PSMA PET may be used instead according to the imaging modality used at staging and clinical judgment. EPIC-CP and IPSS questionnaires are administered at months 3 and 12. After month 24, survival status is assessed every 6 months.
The planned convenience sample is 30 participants. Baseline characteristics and biomarker data are summarised descriptively, and survival outcomes are estimated using Kaplan-Meier methods. Radiological response is planned to be assessed according to RECIST version 1.1; the operational definition across the permitted imaging modalities must be confirmed before release.
- Being tested
- Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node DissectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) assesses prostate cancer-related health-related quality of life across five domains: urinary incontinence, urinary irritation/obstruction, bowel symptoms, sexual symptoms, and vitality/hormonal symptoms. Each domain score ranges from 0 to 12, and the overall score ranges from 0 to 60. Higher scores indicate greater symptom burden and worse health-related quality of life. The five domain scores and the overall score will be summarised descriptively at each assessment time point.
Measured: At 3 months and 12 months after radical prostatectomy.
International Prostate Symptom Score Total Score
The International Prostate Symptom Score (IPSS) is a seven-item patient-reported questionnaire assessing lower urinary tract symptoms. Each item is scored from 0 to 5, resulting in a total score ranging from 0 to 35. Higher scores indicate more severe urinary symptoms. Total scores are classified as mild symptoms (0-7), moderate symptoms (8-19), or severe symptoms (20-35). The total score will be summarised descriptively at each assessment time point.
Measured: At 3 months and 12 months after radical prostatectomy.
Pathological Complete Response Rate
Percentage of participants with no residual prostate carcinoma identified on histopathological examination of the radical prostatectomy specimen following androgen-deprivation therapy
Measured: At radical prostatectomy (Day 0)
PSA Response Rate
Percentage of participants with a decrease in serum PSA of at least 50% from the protocol-defined baseline sample
Measured: From the baseline sample to From the baseline sample to 5 years from last prostatectomy
Serum Testosterone Concentration
Serum testosterone concentration summarised at each scheduled assessment.
Measured: Screening and 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after radical prostatectomy
Serum Alkaline Phosphatase Concentration
Serum alkaline phosphatase concentration summarised at each scheduled assessment
Measured: Screening and 1, 6, 12, 18 and 24 months after radical prostatectomy
Serum C-Terminal Telopeptide Concentration
Serum C-terminal telopeptide of type I collagen concentration, if collected, summarised at each scheduled assessment
Measured: assessment schedule through 24 months from prostatectomy
Incidence of Postoperative Upper and Lower Urinary Tract Complications
Percentage of participants experiencing one or more postoperative complications involving the upper or lower urinary tract after radical prostatectomy
Measured: From surgery through 24 months after radical prostatectomy
Conversion to Open Surgery
Percentage of attempted laparoscopic robot-assisted radical prostatectomy procedures converted to an open surgical approach
Measured: During surgery (Day 0)
Radiological Response to Androgen-Deprivation Therapy
Percentage of participants with a radiological response according to the protocol-defined criteria when pre-treatment imaging is compared with the preoperative assessment after androgen-deprivation therapy
Measured: From pre-ADT baseline imaging to preoperative screening after at least 6 months of androgen-deprivation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start26 Sep 2019
- Primary completion23 Apr 2025
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Hormone-Sensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible participants undergo robot-assisted radical prostatectomy with extended pelvic lymph-node dissection while continuing androgen-deprivation therapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Porpiglia, MD, Principal investigator, FPO-IRCCS Cancer Institute of Candiolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766486
- Sponsor's protocol ID
- 017-FPO19
- Acronym
- MAZINGA
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT07766486
- Acronym / sponsor ID
- MAZINGA / 017-FPO19
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Radical prostatectomy is being investigated as a cytoreductive treatment in selected men with oligometastatic hormone-sensitive prostate cancer who respond to androgen-deprivation therapy (ADT). MAZINGA is a prospective, single-centre, single-group pilot study designed to obtain preliminary estimates of survival and treatment response after the addition of radical prostatectomy to ongoing ADT.
Eligible participants have acinar prostate adenocarcinoma, no more than five bone metastases confined to the spine and/or pelvis, no visceral or retroperitoneal nodal metastases, no bulky pelvic nodes greater than 3 cm, an Eastern Cooperative Oncology Group performance status of 0 or 1, and a PSA level below 4 ng/mL after at least 6 months of ADT. Participants undergo robot-assisted laparoscopic radical prostatectomy with modified extended bilateral pelvic lymph-node dissection. ADT is continued according to the treating oncologist.
PSA and serum testosterone are measured at months 1 and 3 and every 3 months thereafter through month 24. Contrast-enhanced computed tomography of the chest and abdomen plus whole-body bone scintigraphy are performed every 6 months through month 24; PSMA PET may be used instead according to the imaging modality used at staging and clinical judgment. EPIC-CP and IPSS questionnaires are administered at months 3 and 12. After month 24, survival status is assessed every 6 months.
The planned convenience sample is 30 participants. Baseline characteristics and biomarker data are summarised descriptively, and survival outcomes are estimated using Kaplan-Meier methods. Radiological response is planned to be assessed according to RECIST version 1.1; the operational definition across the permitted imaging modalities must be confirmed before release.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible participants undergo robot-assisted radical prostatectomy with extended pelvic lymph-node dissection while continuing androgen-deprivation therapy.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Radical Prostatectomy Plus Ongoing Androgen-Deprivation Therapy | Experimental | Procedure: Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node DissectionParticipants 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 |
Who may qualify
- Ages
- 41 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node DissectionRobot-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 | Procedure or surgery | Arm 1: Radical Prostatectomy Plus Ongoing Androgen-Deprivation Therapy |
Primary outcome
Overall Survival
Time frame: From the date of radical prostatectomy until death from any cause, assessed up to 5 years after radical prostatectomy.
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
Progression-Free Survival
Time frame: 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.
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.
10 secondary outcomes
Expanded Prostate Cancer Index Composite for Clinical Practice Total and Domain Scores
Time frame: At 3 months and 12 months after radical prostatectomy.
International Prostate Symptom Score Total Score
Time frame: At 3 months and 12 months after radical prostatectomy.
Pathological Complete Response Rate
Time frame: At radical prostatectomy (Day 0)
PSA Response Rate
Time frame: From the baseline sample to From the baseline sample to 5 years from last prostatectomy
Serum Testosterone Concentration
Time frame: Screening and 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after radical prostatectomy
Serum Alkaline Phosphatase Concentration
Time frame: Screening and 1, 6, 12, 18 and 24 months after radical prostatectomy
Serum C-Terminal Telopeptide Concentration
Time frame: assessment schedule through 24 months from prostatectomy
Incidence of Postoperative Upper and Lower Urinary Tract Complications
Time frame: From surgery through 24 months after radical prostatectomy
Conversion to Open Surgery
Time frame: During surgery (Day 0)
Radiological Response to Androgen-Deprivation Therapy
Time frame: From pre-ADT baseline imaging to preoperative screening after at least 6 months of androgen-deprivation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Porpiglia, MD principal investigator
FPO-IRCCS Cancer Institute of Candiolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection in people with Oligometastatic Hormone-Sensitive Prostate Cancer and Prostate Adenocarcinoma, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From the date of radical prostatectomy until death from any cause, assessed up to 5 years after radical prostatectomy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.