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

Official record

Identifier

NCT07766486

Recruiting locations

country

Italy

Interventions studied

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

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Target enrolment

30 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Active, not recruiting

First posted

Aug 14, 2026

Last updated on the registry

Aug 14, 2026

Age

41 Years

Sex

MALE

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Prostate Cancer