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Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Proton Radiation Hypofractionation
Proton Radiation Standard Fractionation
Sponsored by
Proton Collaborative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Proton Radiation Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
  • History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.
  • PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
  • Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
  • No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
  • Patients must be at least 18 years old.
  • ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
  • IPSS score <= 16.
  • Patients must give IRB approved, study specific, informed consent.
  • Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
  • Patients must be able to start treatment within 56 days of randomization.

Exclusion Criteria:

  • 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 affecting the rectum, or ulcerative colitis.
  • Prior systemic chemotherapy for prostate cancer.
  • History of proximal urethral stricture requiring dilatation.
  • Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
  • Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.
  • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).

Sites / Locations

  • Mayo Clinic Cancer Center
  • Northwestern Medicine Chicago Proton Center
  • Maryland Proton Treatment Center
  • Oklahoma Proton Center
  • Hampton University Proton Therapy Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Proton Radiation Hypofractionation

Proton Radiation Standard Fractionation

Arm Description

5 fractions (7.6 Gy(RBE) x 5)

44 fractions (1.8 Gy(RBE) x 44)

Outcomes

Primary Outcome Measures

To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.

Secondary Outcome Measures

To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.

Full Information

First Posted
October 27, 2010
Last Updated
April 1, 2023
Sponsor
Proton Collaborative Group
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1. Study Identification

Unique Protocol Identification Number
NCT01230866
Brief Title
Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer
Official Title
A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proton Collaborative Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton Radiation Hypofractionation
Arm Type
Other
Arm Description
5 fractions (7.6 Gy(RBE) x 5)
Arm Title
Proton Radiation Standard Fractionation
Arm Type
Active Comparator
Arm Description
44 fractions (1.8 Gy(RBE) x 44)
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation Hypofractionation
Other Intervention Name(s)
Particle Therapy
Intervention Description
Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation Standard Fractionation
Other Intervention Name(s)
Particle Therapy
Intervention Description
Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks
Primary Outcome Measure Information:
Title
To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
Description
The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.
Time Frame
At 5 years post treatment completion +/- 90 days
Secondary Outcome Measure Information:
Title
To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
Time Frame
At 6 months and 2 years post randomization

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 prior to randomization. History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization. Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended. PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy. Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator. No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative. Patients must be at least 18 years old. ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization. IPSS score <= 16. Patients must give IRB approved, study specific, informed consent. Patients must complete all mandatory tests listed in section 4.0 within the specified time frames. Patients must be able to start treatment within 56 days of randomization. Exclusion Criteria: 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 affecting the rectum, or ulcerative colitis. Prior systemic chemotherapy for prostate cancer. History of proximal urethral stricture requiring dilatation. Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement). Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study. Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Vargas, MD
Organizational Affiliation
Proton Collaborative Group
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Northwestern Medicine Chicago Proton Center
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Maryland Proton Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oklahoma Proton Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73142
Country
United States
Facility Name
Hampton University Proton Therapy Institute
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

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Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

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