N/A
N=228
Proton Therapy for Low and Intermediate Risk Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00693238 ↗Enrolled (actual)
228
Serious AEs
1.8%
Results posted
Jul 2013
Primary outcome: Primary: Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Risk Proton Radiation (Radiation); Intermediate Risk Proton Radiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Florida
- Primary completion
- Jun 2012
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 |
— | — |
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.
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.