Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

NCT ID: NCT05707468

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2028-03-01

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.

Conditions

Oligometastatic Prostate Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A (hormone)

The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.

Group Type: ACTIVE_COMPARATOR

ADT combined with abiraterone

Intervention Type: DRUG

The patients will receive long-term ADT combined with abiraterone.

B (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.

Group Type: EXPERIMENTAL

neoadjuvant hormone and RT

Intervention Type: RADIATION

The patients 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.

Interventions

ADT combined with abiraterone

The patients will receive long-term ADT combined with abiraterone.

Intervention Type: DRUG

neoadjuvant hormone and RT

The patients 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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Huo Jun

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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 Ningbo University

Ningbo, Zhejiang, China

The Second Affiliated Hospital of Naval Medical University

Shanghai, , China

The First Affiliated Hospital of Naval Medical University

Shanghai, , China

Countries

China

Central Contacts

Huojun Zhang, PhD

Role: CONTACT

huojunzh@163.com

021-31162222

Xianzhi Zhao, MD

Role: CONTACT

zhxzh0007@163.com

021-31162222

Facility Contacts

Di Gu, PhD

Role: primary

Xiang Ding, PhD

Role: primary

Ninghan Feng, PhD

Role: primary

Zejun Yan, PhD

Role: primary

Shancheng Ren, PhD

Role: primary

renshancheng@gmail.com

021-81885721

Huojun Zhang, PhD

Role: primary

huojunzh@163.com

021-31162222

References

Fan Z, Li D, Yan S, Zhao X, Yin L, Xu W, Wang Y, Zhang H, Chang Y, Ren S. NEoAdjuvant radiohormonal therapy versus standard of care for oligometastatic prostate cancer (NEAR-TOP): study protocol of a multicenter, open-label, randomised controlled trial. BMC Cancer. 2025 Apr 24;25(1):768. doi: 10.1186/s12885-024-13201-w.

Reference Type: DERIVED

PMID: 40275195 (View on PubMed)

Other Identifiers

Changhai Hospital PCa

Identifier Type: -

Identifier Source: org_study_id