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Proton Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiation Therapy
Quality-of-Life assessment
Questionnaire Administration
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

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
Acute toxicity as assessed by NCI CTC Version 3.0

Secondary Outcome Measures

Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
Biochemical/clinical progression-free survival

Full Information

First Posted
January 5, 2010
Last Updated
January 30, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01045226
Brief Title
Proton Radiation Therapy in Treating Patients With Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
participants are no longer being followed up.
Study Start Date
August 2009 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Procedure
Intervention Name(s)
Proton Beam Radiation Therapy
Intervention Description
Proton Beam Radiation Therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life assessment
Intervention Description
Quality of Life Assessment
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Questionnaire Administration
Primary Outcome Measure Information:
Title
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
Title
Acute toxicity as assessed by NCI CTC Version 3.0
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
Time Frame
90 days
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Proton Radiation Therapy in Treating Patients With Prostate Cancer

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