Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Treatment | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT | Drug | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ADT
- description
- Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.
- interventionNames
- Drug: ADT
- type
- EXPERIMENTAL
- label
- SBRT
- description
- Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
- interventionNames
- Radiation: SBRT
Primary outcomes (3)
- measure
- 1-year ADT-free survival of the experimental group
- timeFrame
- Assessment ADT-free survival of the experimental group at 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhao 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 36180115