Can surgery boost control of spread prostate cancer?
NCT ID NCT07766486
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This study tests whether robot-assisted removal of the prostate, along with lymph node dissection, can help control cancer in men with oligometastatic hormone-sensitive prostate cancer—cancer that has spread to a few spots in the spine or pelvis. Participants have been on hormone therapy for at least six months and have low PSA levels. The trial will track survival, cancer progression, quality of life, and side effects over two years to see if adding surgery to ongoing hormone therapy is beneficial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Robot-assisted radical prostatectomy with extended pelvic lymph-node dissection
- What this could lead to
- If successful, this approach could offer a way to better control oligometastatic prostate cancer, potentially improving survival and delaying progression when combined with hormone therapy.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. Surgery carries risks like urinary complications, and it's unclear if it will improve outcomes over hormone therapy alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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41 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. * Previous finasteride or dutasteride treatment discontinued less than 6 months before enrolment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Direzione di Chirurgia Urologica, INOC, viale della Ricerca 7, 10060 Candiolo, Turin 10060
Candiolo, Torino (TO), 10060, Italy
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