neoadjuvant radiohormonal therapy for oligometastatic prostate cancer

Conditions: Oligometastatic Prostate Carcinoma

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.

the present study will be conducted as a prospective, open-label, two arms clinical trial. patients with ≤ 3 de novo oligometastatic pca, diagnosed on ga-68 prostate-specific membrane antigen (psma) pet/ct, will be randomized in a 1:1 ratio between arm a (hormone) and arm 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. the primary endpoints of the study are progression-free survival (pfs) including biochemical recurrence-free survival (bpfs), and radiological progression-free survival (rpfs). the secondary endpoints include quality of life (qol), time to crpc, positive surgical margin (psm), overall survival (os), postoperative continence, and toxicities parameters.

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.