Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
September 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedAugust 11, 2022
December 1, 2021
2 months
October 10, 2020
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
1-year ADT-free survival of the experimental group
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
Radiotherapy-related complications
Assessment Toxicity at 1 year
The time from inception of the study to castration-resistant prostate cancer (CRPC)
the time from inception of the study to castration-resistant prostate cancer (CRPC)
Assessment at 1 year
Secondary Outcomes (3)
1-year Efficacy Biochemical Progression-free Survival (bPFS)
1 year
1-year Local Progression-Free-Survival(LPFS)
Assessment at 1 year
1-year Distant Metastasis Free Survival(DMFS)
Assessment at 1 year
Study Arms (2)
ADT
ACTIVE COMPARATOREvaluating men with oligometastatic prostate cancer lesions randomized to ADT.
SBRT
EXPERIMENTALEvaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (1)
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.
PMID: 36180115DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 10, 2020
First Posted
October 23, 2020
Study Start
September 11, 2022
Primary Completion
November 11, 2022
Study Completion
October 1, 2025
Last Updated
August 11, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.