Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery
Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy
NCT03541850CI-TRIAL-00097051active not recruitingPhase 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 phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PSA Level Greater Than 0.03 | — | UNRESOLVED | — |
| PSA Progression | — | UNRESOLVED | — |
| Stage III Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage II Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiandrogen Therapy | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT, ADT)
- description
- Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.
- interventionNames
- Drug: Antiandrogen Therapy
- Other: Quality-of-Life Assessment
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (4)
- measure
- Biochemical recurrence-free survival (BCRFS)
- timeFrame
- Up to 5 years
- description
- Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.4 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BCRFS time will be calculated with 95% confidence interval. Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent * Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL * Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: \[a\] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed \[b\] for patients with PSA \< 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan) * Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography \[PET\]/CT) is strongly recommended * Karnofsky performance score (KPS) \>= 70 * Ability to understand, and willingness to sign, the written informed consent Exclusion Criteria: * Patients with any evidence of distant metastases * Patients with pathologically-confirmed N1 prostate cancer * Patients with neuroendocrine or small cell carcinoma of the prostate * Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate * Prior pelvic radiotherapy * History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
References
Publications (2)
- DERIVEDNikitas J, Ballas LK, Romero T, Lynch C, Ma TM, Valle LF, Sachdeva A, Chong N, Basehart V, Franco A, Reiter R, Saigal C, Chamie K, Litwin MS, Donin NM, Rettig M, Nickols NG, Cao M, Liauw SL, Steinberg ML, Kishan AU. Patient-Reported Outcomes With Stereotactic Intensity Modulated Radiotherapy After Radical Prostatectomy: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Jul 1;11(7):726-734. doi: 10.1001/jamaoncol.2025.1059. PMID 40372727
- DERIVEDNikitas J, Smith LM, Gao Y, Ma TM, Sachdeva A, Yoon SM, Jiang T, Low DA, Ballas LK, Steinberg ML, Cao M, Kishan AU. The role of adaptive planning in margin-reduced, MRI-guided stereotactic body radiotherapy to the prostate bed following radical prostatectomy: Post-hoc analysis of a phase II clinical trial. Radiother Oncol. 2023 Jun;183:109631. doi: 10.1016/j.radonc.2023.109631. Epub 2023 Mar 18. PMID 36934894