NCT07268794Toborzás még nem indult2. fázis
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer
A Multicenter, Prospective, Randomized Controlled Phase II Clinical Trial of Prostatectomy After Conversion Therapy With Second-generation Antiandrogen Agents Plus ADT in Patients With High-volume mHSPC(CONVERT-HB1)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 8.
Rövid összefoglaló (regiszter, angolul)
This is a prospective, randomized, open-label, phase II multicenter clinical trial evaluating the efficacy and safety of radical prostatectomy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who achieve good response after systemic therapy with androgen deprivation therapy (ADT) plus second-generation antiandrogens such as rezvilutamide. All eligible patients will receive 6 months of induction systemic therapy (ADT plus second-generation androgen receptor signaling inhibitors, with or without docetaxel or other systemic agents). Patients who achieve PSMA PET/CT "conversion success" (no metabolically active lesions; all metastases with SUVmax below liver background or blood pool) will be randomized 1:1 to continue systemic therapy alone (control arm) or receive local prostate treatment (radical prostatectomy or radiotherapy) plus systemic therapy (experimental arm). The primary endpoint is radiographic progression-free survival (rPFS). Key secondary endpoints include overall survival (OS), biochemical progression-free survival (bPFS), PSA response rate, quality of life, conversion success rate, and safety.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 112 (tervezett)
- Első benyújtás
- 2025. nov. 16.
- Kezdés
- 2025. nov. 30.
- Elsődleges befejezés
- 2027. ápr. 30.
- Fő szponzor
- Fudan University
- Betegségek
- Prosztatarák
- NCT-szám
- NCT07268794
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 112
- 2025. nov. 30. és az elsődleges befejezés (2027. ápr. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- History of seizure, medications that may lower seizure threshold, or conditions predisposing to seizures (e.g., TIA, stroke, significant head trauma with loss of consciousness requiring hospitalization) within 12 months before starting study treatment.
- Major surgery within 4 weeks prior to starting study treatment.
- Concurrent participation in another interventional clinical trial or receiving other investigational drugs/devices.
Más betegség
- History of hypersensitivity or intolerance to any study drugs.
- mCRPC (metastatic castration-resistant prostate cancer).
- Significant cardiovascular or cerebrovascular disease within 6 months (e.g., unstable angina, myocardial infarction, NYHA class III or higher heart failure, stroke, clinically significant arrhythmia requiring treatment).
- Conditions affecting drug intake or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction).
- Active infection (e.g., HIV positive, HBsAg positive, HCV positive) which in the investigator's opinion may affect safety or efficacy assessment.
- Other malignancies within the past 3 years, except adequately treated basal cell carcinoma of the skin.
- Known brain metastases or leptomeningeal disease.
- Any other severe uncontrolled comorbidities (e.g., poorly controlled hypertension, severe diabetes, neurologic or psychiatric disorders) or conditions that may interfere with study conduct or interpretation, as judged by the investigator.
Egyéb
- Oligometastatic mHSPC intended for upfront radical prostatectomy.
- Poor compliance or inability to adhere to study procedures and follow-up.
Kiket keres a vizsgálat
- Male patients aged >18 and ≤70 years, or with an estimated life expectancy >10 years.
- Histologically or cytologically confirmed prostate adenocarcinoma with neuroendocrine differentiation ≤10%, and no small cell or signet-ring cell carcinoma component.
- High-volume metastatic disease according to CHAARTED definition: presence of visceral metastasis and/or ≥4 bone lesions with at least one lesion outside the axial skeleton (vertebral bodies and pelvis).
- Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who started intensified endocrine therapy within 3 months.
- ECOG performance status 0-2.
- Adequate bone marrow, liver, renal, and coagulation function as defined in the protocol (ANC ≥1.5×10\^9/L, hemoglobin ≥9.0 g/dL, platelets ≥80×10\^9/L; TBIL ≤1.5×ULN; AST/ALT/ALP ≤2.5×ULN; albumin ≥30 g/L; creatinine ≤2×ULN or creatinine clearance ≥30 mL/min; INR ≤1.5 in patients not receiving anticoagulation).
- Patients voluntarily sign informed consent and are willing and able to comply with study procedures.
Életkor a regiszterben: 18 év – 70 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 |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Kína | Ismeretlen állapot |
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