NCT07766486Fut, nem toboroz
Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 14.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. aug. 6.
- Kezdés
- 2019. szept. 26.
- Elsődleges befejezés
- 2025. ápr. 23.
- Fő szponzor
- Fondazione del Piemonte per l'Oncologia
- Betegségek
- Prosztatarák
- NCT-szám
- NCT07766486
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2019. szept. 26. és az elsődleges befejezés (2025. ápr. 23.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- PSA greater than 100 ng/mL at diagnosis before starting androgen-deprivation therapy.
- Concomitant treatment with other antineoplastic agents, including investigational endocrine therapies.
- 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.
- 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.
- Previous finasteride or dutasteride treatment discontinued less than 6 months before enrolment.
Más betegség
- History of pituitary or adrenal insufficiency.
- 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.
- Acute or chronic hepatitis.
- Dementia or psychiatric illness that limits compliance with study requirements or may prevent understanding or signing the informed-consent form.
Laborértékek
- Hypogonadism or severe androgen deficiency defined as serum testosterone below 100 ng/dL.
Egyéb
- Special histological subtypes of prostate carcinoma
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 41 év – - · Nem: csak férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Direzione di Chirurgia Urologica, INOC, viale della Ricerca 7, 10060 Candiolo, Turin 10060 Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Candiolo | Olaszország | Ismeretlen állapot |
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