Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments < 15% risk of + ln, > 15% risk of + ln
Phase phase 2
Sponsor University of Florida
Start date December 2009
End date January 2015
Trial size 77 participants
Trial identifier NCT01040624, UFPTI 0703 - PR05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
< 15% risk of + LN
< 15% risk of + ln
Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
(Experimental)
> 15% risk of + LN
> 15% risk of + ln
Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.

Primary Outcomes

Measure
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
time frame: 6 months after the completion of radiation therapy

Secondary Outcomes

Measure
Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
time frame: After radiation: every 6 months for 3 years, then annually for 20 years
Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
time frame: After radiation: every 6 months for 3 years, then annually for 20 years

Eligibility Criteria

Male participants at least 18 years old.

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 MI (myocardial infarction) or CHF (congestive heart failure). - Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Additional Information

Official title A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
Principal investigator Nancy P Mendenhall, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Florida.