Clinical trial · Interventional
Hypofractionated SBRT For Prostate Cancer
Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
- 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 purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- SBRT
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (3)
- measure
- Rate of Acute Grade 3 or Higher GI and GU Toxicities
- timeFrame
- Up to 90 days
- description
- Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.
- measure
- Rate of Late Grade 3 or Higher GI and GU Toxicities
- timeFrame
- After 90 days post-treatment, up to 5 years per patient
- description
- Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate adenocarcinoma * Gleason score 2-7 * Biopsy within one year of date of registration * Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition) * T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI) * M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases. * PSA ≤ 20 ng/dL * Patients belonging in one of the following risk groups: * Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or * Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL * Prostate volume: ≤ 100 cc * Determined using: volume = π/6 x length x height x width * Measurement from CT or ultrasound ≤90 days prior to registration. * ECOG performance status 0-1 * Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire * Consent signed. Exclusion Criteria: * Prior prostatectomy or cryotherapy of the prostate * Prior radiotherapy to the prostate or lower pelvis * Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. * Chemotherapy for a malignancy in the last 5 years. * History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years. * Hormone ablation for two months prior to enrollment, or during treat
References
Publications (0)
Data not yet available