Clinical trial · Interventional
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
NCT04489745CI-TRIAL-00046219unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a trial of 5 fraction SBRT combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy (ADT) | Drug | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT and ADT
- description
- Patients undergo SBRT to a dose of 40 Gy in 5 fractions to prostate, and optional 25 Gy in 5 fractions to SVs and Pelvic LNs, with 9 months of Androgen Deprivation Therapy
- interventionNames
- Radiation: SBRT
- Drug: Androgen deprivation therapy (ADT)
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 5 years
- description
- progression is defined by biochemical (phoenix definition), clinical, or radiographic
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary non-metastatic adenocarcinoma of the prostate * High-risk or unfavorable intermediate-risk as defined below: High-risk localized prostate cancer, as defined by any one of the following factors: Pre-biopsy or any PSA ≥20 prior to enrollment, or Gleason score 8 or higher on any biopsy core, or cT3a or higher. Unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors: Gleason score of 4+3 or higher on any biopsy core, or Gleason score 3+4 and \>50% biopsy cores positive, or The presence of any two of the following: PSA\>10, cT2b-c, Gleason score 3+4 in any core * No pelvic nodal metastases (based on CT or MRI findings) * No distant metastases, based upon: CT scan or MRI of the pelvis within 120 days prior to registration, Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis * Age ≥ 18 * KPS ≥ 70 (or ECOG 0-2) * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for SBRT off-trial as a standard of care option) * Patients with any evidence of distant metastases * Hormonal therapy (LHRH agonist or oral anti-androgen) exceeding 7 months prior to registration * Prior cryosurgery, HIFU or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn's Disease or Ulcerative Colitis
References
Publications (0)
Data not yet available
No reference posted for this study.