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Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04599686
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
Zhang Huo Jun, Changhai Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Treatment Drug: ADT Radiation: SBRT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial
Estimated Study Start Date : September 11, 2022
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. The Probability of Radiotherapy-related Toxicity [ Time Frame: Assessment Toxicity at 1 year ]
    Radiotherapy-related complications

  3. 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)


Secondary Outcome Measures :
  1. 1-year Efficacy Biochemical Progression-free Survival (bPFS) [ Time Frame: 1 year ]
    Biochemical Progression-free Survival (bPFS)

  2. 1-year Local Progression-Free-Survival(LPFS) [ Time Frame: Assessment at 1 year ]
    Local Progression-Free-Survival(LPFS)

  3. 1-year Distant Metastasis Free Survival(DMFS) [ Time Frame: Assessment at 1 year ]
    Distant Metastasis Free Survival(DMFS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599686


Contacts
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Contact: Huojun Zhang, PhD 021-31162222 chyyzhj@163.com
Contact: Xianzhi Zhao, MD 021-31162222 zhxzh0007@163.com

Locations
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China, Shanghai
Changhai hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Huojun Zhang, M.D.    021-31162222    chyyzhj@163.com   
Principal Investigator: Huojun Zhang, M.D.         
Sponsors and Collaborators
Changhai Hospital
More Information
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Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NCT04599686
Please see the clinical trials NCT04599686

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhang Huo Jun, Clinical Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT04599686    
Other Study ID Numbers: Changhai Ho
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
Supporting Materials: Study Protocol
Time Frame: Within 5 years after the publication of the study.
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.
URL: http://clinicaltrials.gov/ct2/show/NCT04599686?term=NCT04599686&draw=2&rank=1

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhang Huo Jun, Changhai Hospital:
SBRT
Oligometastatic Prostate Cancer
Feasibility
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases