Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
Oligometastatic Prostate Carcinoma
About this trial
This is an interventional treatment trial for Oligometastatic Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate without small cell features Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT <4 bone oligometastases, lymph node metastasis below the renal artery level Expected survival time >5 years World Health Organization (WHO) performance status 0-1 Be 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 months Patients who have visceral metastases Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis Severe or active comorbidities likely to impact the advisability of radiotherapy Any 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 patient Patients who have participated in other clinical trials within the last 3 months Patients who refuse to undergo RALP Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- the First Affiliated Hospital of Guangzhou Medical University
- Zhongda Hospital Southeast University
- First Affiliated Hospital and Medical College of Soochow University
- Shanghai Changzheng Hospital
- Shanghai Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
A (hormone)
B (neoadjuvant hormone and RT)
The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.
The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.