Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

August 9, 2022 updated by: Zhang Huo Jun, Changhai Hospital

Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial

The aim of this study is to test the safety and feasibility of SBRT without ADT in oligometastatic prostate cancer in patients for whom the standard treatment is ADT, and to further explore how long only radiotherapy for oligometastases can prolong biochemical progression-free survival (bPFS). In this study, men with oligometastatic prostate cancer lesions will be randomized (1:1) to ADT versus SBRT. Within 6 weeks of the oligometastases diagnosis, ADT or SBRT (30-50Gy with 3-5 fractions) will be administered.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The oligometastatic disease state is an increasingly recognized phenomenon in prostate cancer. Ga-68 PSMA PET/CT has high accuracy in the diagnosis metastases from prostate cancer. In this protocol, pretreatment Ga-68 PSMA PET/ CT shall be performed in all patients.

ADT is considered standard of care treatment for advanced prostate cancer. But hormonal therapy can have side effects that greatly trouble men and lead to castration-resistant prostate cancer (CRPC). Any effort to delay the start of hormonal therapy would be an advantage to the patient. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. SBRT has been shown to be very effective on bone or lymph nodes metastases. Therefore, we are studying the safety and feasibility of SBRT on patients with five or fewer prostate cancer bone or lymph nodes metastases to determine if we can stall the use of hormonal therapy and/or prevent other site metastases from developing elsewhere in the body.

Study Type

Interventional

Enrollment (Anticipated)

100

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

  • Name: Huojun Zhang, PhD
  • Phone Number: 021-31162222
  • Email: chyyzhj@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Principal Investigator:
          • Huojun Zhang, M.D.
        • Contact:

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

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 80 years old

    • Histologically confirmed adenocarcinoma of the prostate
    • Prostate cancer treated with curative intent (radical prostatectomy, primary radiotherapy, or a combination of both)
    • Ga-68 prostate-specific membrane antigen (PSMA) PET/CT evidence of one to three metastases (bone or lymph node) within 6 weeks of enrolment, if the position of oligometastases is judged by the doctor to be in the same radiotherapy area, the number of metastases can be appropriately increased to 5
    • Without ADT treatment
    • PSA< 50ng/ml
    • ECOG performance status 0-2
    • Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures

Exclusion Criteria:

  • Any previous or ongoing treatment of oligometastases including radiotherapy, ADT, chemotherapy, focal treatment, etc.
  • Unstable lesions with spinal or long bone metastases

  • A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI

    • 4 metastases, or if the metastases are in the same radiotherapy area, ≥6 metastases
  • Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate
  • Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc.
  • Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc.
  • Patients who have participated in other clinical trials for less than three months
  • Unsuitable to participate in this clinical trial judged by 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: ADT
Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.
Drug: ADT
On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
Experimental: SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
Radiation: SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year ADT-free survival of the experimental group
Time Frame: Assessment ADT-free survival of the experimental group at 1 year
To assess ADT-free survival of the experimental group
Assessment ADT-free survival of the experimental group at 1 year
The Probability of Radiotherapy-related Toxicity
Time Frame: Assessment Toxicity at 1 year
Radiotherapy-related complications
Assessment Toxicity at 1 year
The time from inception of the study to castration-resistant prostate cancer (CRPC)
Time Frame: Assessment at 1 year
the time from inception of the study to castration-resistant prostate cancer (CRPC)
Assessment at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Efficacy Biochemical Progression-free Survival (bPFS)
Time Frame: 1 year
Biochemical Progression-free Survival (bPFS)
1 year
1-year Local Progression-Free-Survival(LPFS)
Time Frame: Assessment at 1 year
Local Progression-Free-Survival(LPFS)
Assessment at 1 year
1-year Distant Metastasis Free Survival(DMFS)
Time Frame: Assessment at 1 year
Distant Metastasis Free Survival(DMFS)
Assessment at 1 year

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 11, 2022

Primary Completion (Anticipated)

November 11, 2022

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

October 10, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai Ho

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 who are interested in examining the efficacy and toxicity of oligometastatic prostate cancer treated with stereotactic body radiotherapy (SBRT) or androgen deprivation therapy (ADT). 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

Study Data/Documents

  1. Study Protocol
    Information identifier: NCT04599686
    Information comments: Please see the clinical trials NCT04599686

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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