Proton Radiation Therapy in Treating Patients With Prostate Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Detailed Description
PRIMARY OBJECTIVES:
- Feasibility of proton radiation therapy (RT) using standard fractionation.
SECONDARY OBJECTIVES:
-
To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation.
-
To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years.
-
To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years.
-
To assess incidence of impotence after the use of proton therapy at 3 years.
-
To determine freedom from biochemical failure (BF) at 5 years.
-
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.
-
To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years.
-
Estimate prostate and normal structures movement during RT with the use of scans.
-
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.
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. |
Procedure: Proton Beam Radiation Therapy
Proton Beam Radiation Therapy
Other: Quality-of-Life assessment
Quality of Life Assessment
Other: Questionnaire Administration
Questionnaire Administration
|
Outcome Measures
Primary Outcome Measures
- As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility [5 years]
- Acute toxicity as assessed by NCI CTC Version 3.0 [90 days]
Secondary Outcome Measures
- Late toxicity as assessed by RTOG/EORTC late morbidity scoring system [90 days]
- Biochemical/clinical progression-free survival [Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 08809
- NCI-2009-01500