Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
NCT01923506CI-TRIAL-00125169active not recruitingPhase 1ClinicalTrials.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 I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and 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 |
|---|---|---|---|
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SBRT)
- description
- Patients receive 5 fractions of SBRT over 1.5 weeks.
- interventionNames
- Radiation: stereotactic body radiation therapy
- Procedure: quality-of-life assessment
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
- 90 days
- description
- Tables will be created to summarize these toxicities and side effects by dose level.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * History of diagnosis of prostate cancer after undergoing prostatectomy * No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic * Eastern Cooperative Oncology Group (ECOG) performance scale 0-2 * Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable * Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry * PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion * All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active infection * Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy * Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years * Study-specific exclusions: * History of prior radiation to the pelvis * History of uncontrolled inflammatory bowel disease * Unable to comply with radiation therapy procedures * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
References
Publications (0)
Data not yet available
No reference posted for this study.