Clinical trial · Interventional
Proton Radiation Therapy in Treating Patients With Prostate Cancer
A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
NCT01045226CI-TRIAL-00063604terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): participants are no longer being followed up.
Summary
Brief summary (as posted)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Radiation Therapy | Procedure | — | UNRESOLVED |
| Quality-of-Life assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: Proton Beam Radiation Therapy
- Other: Quality-of-Life assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
- timeFrame
- 5 years
- measure
- Acute toxicity as assessed by NCI CTC Version 3.0
- timeFrame
- 90 days
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma within 365 days of registration * Clinical stages T1a-T2a N0 M0 * For any pelvic lymph node \>= 1.5cm, biopsy of the lymph node is mandatory * Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; \> 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion * PSA values \< 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy. * Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated \> 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases * Zubrod status 0-1 documented within 60 days of registration * Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy * Patients must give IRB-approved study-specific informed consent * Patients must complete all required tests listed within the specified time frames * Patients must be able to start treatment within 56 days of registration * Members of all races and ethnic groups are eligible for this trial Exclusion Criteria: * Clinical stages T2c or greater * PSA of 10 ng/ml or greater * Gleason score 7 or higher * Evidence of distant metastasis * Evidence of lymph node involvement * Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery * Previous pelvic radiation for prostate cancer * Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy * Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed * Prior systemic chemotherapy for prostate cancer * History of proximal urethral stricture requiring dilatation
References
Publications (0)
Data not yet available
No reference posted for this study.