Clinical trial · Interventional
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
NCT00585962CI-TRIAL-00029418completedPhase 2ClinicalTrials.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)
The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.
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 |
|---|---|---|---|
| Proton Beam Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5. * PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy. * Zubrod status 0-1. * No evidence of distant metastasis. * No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years. Exclusion Criteria: * Clinical stages T2c or above. * PSA greater than 15. * Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6. * Evidence of lymph node involvement if lymph node sampling performed. * Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery. * Previous prostate radiation. * Prior hormonal therapy. * History of inflammatory bowel disease even if currently inactive or controlled on medication. * Prior systemic chemotherapy. * History of proximal urethral stricture requiring dilatation. * Current and continuing anticoagulation with Coumadin or equivalent. * Major medical or psychiatric illness
References
Publications (0)
Data not yet available
No reference posted for this study.