N/A
Completed N=228
Proton Therapy for Low and Intermediate Risk Prostate Cancer
Source: ClinicalTrials.gov NCT00693238 ↗Enrolled (actual)
228
Serious AEs
1.8%
Results posted
Jul 2013
Primary outcomePrimary: Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. — 0; 0 Participants
Summary
The purpose of this trial is to give a shorter course (5 ½ weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. |
0; 0 | — |
| SECONDARY Disease Control |
— | — |
Eligibility Criteria
Inclusion Criteria
- Prostate cancer.
- Gleason score 2-7.
- PSA ≤ 20 ng/ml.
Exclusion Criteria
- Previous prostate cancer surgery or pelvic radiation.
- Prior or current chemotherapy for prostate cancer.
- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
- History of proximal urethral stricture requiring dilatation.
- History of hip replacement.
- Diabetes requiring medication.
- Prior intrapelvic surgery.
- Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
- On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Data sourced from ClinicalTrials.gov (NCT00693238). 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.