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Not Yet Recruiting
NCT05707468
Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
Conditions: Oligometastatic Prostate Carcinoma
Sex: Male
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 200
Sponsor: Changhai Hospital
Location: China
Summary
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way.
Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients.
The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.
Eligibility Criteria
Inclusion Criteria:Histologically confirmed adenocarcinoma of the prostate without small cell featuresOligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT<4 bone oligometastases, lymph node metastasis below the renal artery levelExpected survival time >5 yearsWorld Health Organization (WHO) performance status 0-1Be willing to give written informed consent.Exclusion Criteria:Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc.Patients who have previously undergone transurethral resection or enucleation of the prostate.Patients who have undergone other abdominal surgery within the last 3 monthsPatients who have visceral metastasesPatients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registrationPatients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilisSevere or active comorbidities likely to impact the advisability of radiotherapyAny other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patientPatients who have participated in other clinical trials within the last 3 monthsPatients who refuse to undergo RALPPatients unsuitable for participation in this clinical trial as per the judgement of the investigator.
Source: ClinicalTrials.gov (NCT05707468). StuddyBuddy aggregates publicly available trial information.