A Feasibility Trial of Proton Radiation Therapy Using Standard Fractionation for Low-Risk Adenocarcinoma of the Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Feasibility Trial of Proton Radiation Therapy Using Standard Fractionation for Low-Risk Adenocarcinoma of the Prostate
Detailed Description
PRIMARY OBJECTIVES:
I. Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free
survival) with standard fractionation.
II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at
6 months, 2 years and 3 years.
III. To assess quality of life issues following completion of radiation therapy at 6 months
and at 2 years.
IV. To assess incidence of impotence after the use of proton therapy at 3 years.
V. To determine freedom from biochemical failure (BF) at 5 years.
VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine
salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free
survival: using clinical, biochemical and SAD as events at 5 years.
IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5
years.
XI. Estimate prostate and normal structures movement during RT with the use of scans.
XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate
PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and
variation with proton therapy and outcomes at 5 years.
XV. Develop a quality assurance process for proton prostate therapy.
OUTLINE:
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5
years, and then annually thereafter.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
Outcome Time Frame:
5 years
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
UPCC 08809
NCT ID:
NCT01045226
Start Date:
August 2009
Completion Date:
August 2014
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
