Clinical trial · Interventional
Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
- 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 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.
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 |
|---|---|---|---|
| hypofractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated radiation therapy in prostate adenocarcinoma
- description
- Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
- interventionNames
- Radiation: hypofractionation
Primary outcomes (4)
- measure
- Number of Participants With Grade 2 or Greater GU and GI Toxicity
- timeFrame
- Up to 5 years
- description
- Assess the number of participants of grade 2 or greater GU and GI toxicity
- measure
- 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
- timeFrame
- Baseline, 12 -, 24 -, and 36-month follow-up
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available