Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

February 19, 2024 updated by: Zhang Huo Jun, Changhai Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200003
        • The Second Affiliated Hospital of Naval Medical University
        • Contact:
      • Shanghai, China, 200433
        • The First Affiliated Hospital of Naval Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Di Gu, PhD
    • Jiangsu
      • Suzhou, Jiangsu, China
        • First Affiliated Hospital and Medical College of Soochow University
        • Contact:
          • Xiang Ding, PhD
      • Wuxi, Jiangsu, China, 210009
        • Jiangnan University Medical Center
        • Contact:
          • Ninghan Feng, PhD
    • Zhejiang
      • Ningbo, Zhejiang, China
        • The First Affiliated Hospital of Ningbo University
        • Contact:
          • Zejun Yan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A (hormone)
The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.
Drug: ADT combined with abiraterone
The patients will receive long-term ADT combined with abiraterone.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year progression-free survival (PFS)
Time Frame: 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).
Assessment progression-free survival (PFS) at 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

January 28, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai Hospital PCa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.

IPD Sharing Time Frame

Within 5 years after the publication of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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