N/A
Completed N=163
Hypofractionated SBRT For Prostate Cancer
Source: ClinicalTrials.gov NCT00977860 ↗Enrolled (actual)
163
Serious AEs
1.2%
Results posted
May 2024
Primary outcomePrimary: Rate of Acute Grade 3 or Higher GI and GU Toxicities — 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Acute Grade 3 or Higher GI and GU Toxicities |
2 | — |
| PRIMARY Rate of Late Grade 3 or Higher GI and GU Toxicities |
— | — |
| PRIMARY Biochemical Disease-Free Survival Rate (bDFS) |
7 | — |
| SECONDARY Rate of Local Failure |
— | — |
| SECONDARY Rate of Distant Failure |
— | — |
| SECONDARY 5-year Overall Survival (OS) |
93.87 | — |
| SECONDARY Quality of Life (QoL) - FACT-G - Prior to Therapy |
26.06019; 23.70186; 19.58; 23.44; 92.78983 | — |
| SECONDARY Quality of Life (QoL) - FACT-G - At 24 Months |
26.10; 21.95238; 21.25; 22.85; 93.15000 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00977860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.