Proton Radiation Therapy in Treating Patients With Prostate Cancer

A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Proton Beam Radiation Therapy; Other: Quality-of-Life assessment; Other: Questionnaire Administration

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 8, 2010

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UPCC 08809; NCI-2009-01500