Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Not Applicable

Not yet recruiting

• Conditions: Oligometastatic Prostate Carcinoma
• Interventions: Drug: ADT combined with abiraterone; Radiation: neoadjuvant hormone and RT

• Registration Number: NCT05707468
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2023-01-28
• Study First Posted: 2023-02-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Study Start: 2024-05-01
• Primary Completion: 2025-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (hormone)	ADT combined with abiraterone	The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.
B (neoadjuvant hormone and RT)	neoadjuvant hormone and RT	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.

Primary Outcome Measures

Name	Time	Method
3-year progression-free survival (PFS)	Assessment progression-free survival (PFS) at 3 years	To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).

Secondary Outcome Measures

Name	Time	Method
quality of life (QoL)	through study completion, an average of 3 years	quality of life (QoL)
time to castration-resistant prostate cancer (CRPC)	through study completion, an average of 3 years	To assess the time to castration-resistant prostate cancer (CRPC)
5-year overall survival (OS)	Assessment overall survival (OS) at 5 years	To assess the overall survival (OS)

Trial Locations

Locations (6)

The Second Affiliated Hospital of Naval Medical University; 🇨🇳 Shanghai, China

The First Affiliated Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China

the First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

First Affiliated Hospital and Medical College of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Jiangnan University Medical Center; 🇨🇳 Wuxi, Jiangsu, China

The First Affiliated Hospital of Naval Medical University; 🇨🇳 Shanghai, China