Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Official title

Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial

Overview

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.

Interventions

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

Primary outcome measures

• 3-year progression-free survival (PFS) [Time frame: Assessment progression-free survival (PFS) at 3 years]

Secondary outcome measures (3)

• quality of life (QoL) [Time frame: through study completion, an average of 3 years]
• time to castration-resistant prostate cancer (CRPC) [Time frame: through study completion, an average of 3 years]
• 5-year overall survival (OS) [Time frame: Assessment overall survival (OS) at 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• the First Affiliated Hospital of Guangzhou Medical University — Guangzhou
• First Affiliated Hospital and Medical College of Soochow University — Suzhou
• Jiangnan University Medical Center — Wuxi
• The First Affiliated Hospital of Ningbo University — Ningbo
• The Second Affiliated Hospital of Naval Medical University — Shanghai
• The First Affiliated Hospital of Naval Medical University — Shanghai

Publications

• 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

Identifiers

NCT: NCT05707468 · Changhai Hospital PCa

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗