Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

NCT05707468 | Not Yet Recruiting

• 1 other identifier: Changhai Hospital PCa
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Oligometastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival (PFS)

  To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).

  Assessment progression-free survival (PFS) at 3 years

Secondary Outcomes (3)

• quality of life (QoL)

  through study completion, an average of 3 years

• time to castration-resistant prostate cancer (CRPC)

  through study completion, an average of 3 years

• 5-year overall survival (OS)

  Assessment overall survival (OS) at 5 years

Study Arms (2)

A (hormone)

ACTIVE COMPARATOR

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

Drug: ADT combined with abiraterone

B (neoadjuvant hormone and RT)

EXPERIMENTAL

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.

Radiation: neoadjuvant hormone and RT

Interventions

ADT combined with abiraterone DRUG

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

A (hormone)

neoadjuvant hormone and RT 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.

B (neoadjuvant hormone and RT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (6)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

First Affiliated Hospital and Medical College of Soochow University

Suzhou, Jiangsu, China

Location

Jiangnan University Medical Center

Wuxi, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

The Second Affiliated Hospital of Naval Medical University

Shanghai, 200003, China

Location

The First Affiliated Hospital of Naval Medical University

Shanghai, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 40275195 DERIVED

MeSH Terms

Interventions

abiraterone

Central Study Contacts

Huojun Zhang, PhD

CONTACT

021-31162222; huojunzh@163.com

Xianzhi Zhao, MD

CONTACT

021-31162222; zhxzh0007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT).

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 1, 2023
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 5 years after the publication of the study.
• Access Criteria: Data may be shared with radiation oncologists and specialists in surgerywho are interested in examining the efficacy and toxicity of oligometastatic prostate cancer treated withneoadjuvant radiohormonal therapy or androgen deprivation therapy (ADT) combined with abiraterone. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (6)