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Proton Radiation Therapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01045226
Recruitment Status : Active, not recruiting
First Posted : January 8, 2010
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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
Prostate Cancer Procedure: Proton Beam Radiation Therapy Other: Quality-of-Life assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

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 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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate
Study Start Date : August 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Primary Outcome Measures :
  1. As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility [ Time Frame: 5 years ]
  2. Acute toxicity as assessed by NCI CTC Version 3.0 [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Late toxicity as assessed by RTOG/EORTC late morbidity scoring system [ Time Frame: 90 days ]
  2. Biochemical/clinical progression-free survival [ Time Frame: 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01045226

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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01045226    
Other Study ID Numbers: UPCC 08809
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases