Clinical trial · Interventional
This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.
Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
- 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)
There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.
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 |
|---|---|---|---|
| Recurrent Prostate Cancer After Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily-adaptive Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1 - Prostate bed only recurrence
- description
- Patients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.
- interventionNames
- Radiation: Daily-adaptive Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- 2- Pelvic nodal with or without a prostate bed recurrence
- description
- Patients who have a radiologic recurrence of prostate cancer in the pelvic node region
- interventionNames
- Radiation: Daily-adaptive Stereotactic Body Radiation Therapy
Primary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the prostate with previous surgical resection * Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation * Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field * At least two serum detectable PSA levels defined as \>0.02 ng/dl at least 30 days apart. Exclusion Criteria: * Metastatic disease * Prior radiation therapy to the pelvis region * Inflammatory bowel disease * Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months * Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months * PSA \>10 ng/dl at study entry,
References
Publications (0)
Data not yet available