We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 10, 2020
First Posted Date  ICMJE October 23, 2020
Last Update Posted Date August 11, 2022
Estimated Study Start Date  ICMJE September 11, 2022
Estimated Primary Completion Date November 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • 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
  • The Probability of Radiotherapy-related Toxicity [ Time Frame: Assessment Toxicity at 1 year ]
    Radiotherapy-related complications
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • 1-year Efficacy Biochemical Progression-free Survival (bPFS) [ Time Frame: 1 year ]
    Biochemical Progression-free Survival (bPFS)
  • 1-year Local Progression-Free-Survival(LPFS) [ Time Frame: Assessment at 1 year ]
    Local Progression-Free-Survival(LPFS)
  • 1-year Distant Metastasis Free Survival(DMFS) [ Time Frame: Assessment at 1 year ]
    Distant Metastasis Free Survival(DMFS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
Official Title  ICMJE Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment
Intervention  ICMJE
  • Drug: ADT
    On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
  • Radiation: SBRT
    Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
Study Arms  ICMJE
  • Active Comparator: ADT
    Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.
    Intervention: Drug: ADT
  • Experimental: SBRT
    Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
    Intervention: Radiation: SBRT
Publications * Zhao X, Wang T, Ye Y, Li J, Gao X, Zhang H. Stereotactic body radiotherapy (SBRT) versus androgen deprivation therapy (ADT) for oligometastatic prostate cancer: protocol for a prospective randomised control clinical trial. BMJ Open. 2022 Sep 30;12(9):e051371. doi: 10.1136/bmjopen-2021-051371.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2020)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2025
Estimated Primary Completion Date November 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Huojun Zhang, PhD 021-31162222 chyyzhj@163.com
Contact: Xianzhi Zhao, MD 021-31162222 zhxzh0007@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04599686
Other Study ID Numbers  ICMJE Changhai Ho
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Zhang Huo Jun, Changhai Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Changhai Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP