Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Treatments: Hormones

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.