Phase 2
Completed N=91
Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
Source: ClinicalTrials.gov NCT00809991 ↗Enrolled (actual)
91
Serious AEs
1.1%
Results posted
Feb 2026
Primary outcomePrimary: Number of Participants With Grade 2 or Greater GU and GI Toxicity — 9; 2; 1; 1 Participants
Summary
This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 2 or Greater GU and GI Toxicity |
9; 2; 1; 1; 2; 1 | — |
| PRIMARY Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) -IPSS |
8.89; 12.9; 7.75; 7.00 | — |
| PRIMARY The Sexual Health Inventory for Men (SHIM) SCORE - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) |
15.5; 12.9; 11.6; 15.5 | — |
| PRIMARY EPIC Sexual Score - Self-reported Quality of Life Data With Image-guided Radiation Therapy in Doses of 3.6 Gy Per Day to a Total Dose of 57.6Gy (16 Fractions) |
80.1; 61.1; 60.3; 62.1 | — |
| SECONDARY Number of Patients With Biochemical Failure Associated With the Hypofractionated Dose Regimen |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- Clinical stages T1a to T2b PSA of less than 10 ng per ml
- Gleason score of less than 3+4=7
- The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer
- Signed study-specific consent form prior to registration
Exclusion Criteria
- Stage T3 to 4 disease
- Gleason 4+3=7 or higher score
- PSA greater than 10 ng per ml
- Clinical or Pathological Lymph node involvement N1
- Evidence of distant metastases M1
- Radical surgery for carcinoma of the prostate
- Previous Chemotherapy or pelvic radiation therapy
- Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
- History of inflammatory bowel disease
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up
Data sourced from ClinicalTrials.gov (NCT00809991). 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.