N/A
N=77
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01040624 ↗Enrolled (actual)
77
Serious AEs
5.2%
Results posted
Jul 2015
Primary outcome: Primary: Acute Grade 3 or Higher Treatment-related Toxicity Rate. — 1; 3 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- < 15% risk of + LN (Radiation); > 15% risk of + LN (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Florida
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Grade 3 or Higher Treatment-related Toxicity Rate. |
1; 3 | <0.0001 sig |
| SECONDARY Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters. |
— | — |
| SECONDARY Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes. |
— | — |
Summary
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
Eligibility Criteria
Inclusion Criteria
- Adenocarcinoma of the prostate.
Exclusion Criteria
- Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
- Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
- History of hip replacement.
- Prior intrapelvic surgery. This includes the following:
- Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
- Transabdominal pelvic surgery
- Bladder surgery
- Prior myocardial infarction (MI) or congestive heart failure (CHF).
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Data sourced from ClinicalTrials.gov (NCT01040624). 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.