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A Feasibility Trial of Proton Radiation Therapy Using Standard Fractionation for Low-Risk Adenocarcinoma of the Prostate

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Feasibility Trial of Proton Radiation Therapy Using Standard Fractionation for Low-Risk Adenocarcinoma of the Prostate

Detailed Description


I. Feasibility of proton radiation therapy (RT) using standard fractionation.


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

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.


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

- 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:


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:



United States: Institutional Review Board

Study ID:

UPCC 08809



Start Date:

August 2009

Completion Date:

August 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283