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

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Radiation: Proton Radiation Hypofractionation Radiation: Proton Radiation Standard Fractionation	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:

To determine if hypo-fractionation will result in freedom from failure (FFF) that is equivalent to FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy. [ Time Frame: At 5 years post treatment completion +/- 90 days ] [ Designated as safety issue: No ]
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 [ Time Frame: At 6 months, 2 years and estimate at 3 years after treatment completion ] [ Designated as safety issue: Yes ]
To assess quality of life issues following completion of radiation therapy [ Time Frame: At 6 months and at 2-years ] [ Designated as safety issue: No ]
To assess incidence of impotence after the use of proton therapy [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
To determine freedom from biochemical failure (BF) [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
To determine clinical failure: local and/or distant [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
To determine salvage androgen deprivation use (SAD) [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To determine progression free survival: using clinical, biochemical and SAD as events [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
To determine overall survival [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
To determine disease-specific survival [ Time Frame: At 5 years ] [ Designated as safety issue: Yes ]
To estimate prostate and normal structures movement during RT with the use of scans [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To correlate pathologic and radiologic findings with outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To correlate PSA and free PSA levels with outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To correlate Testosterone levels and variation with proton therapy and outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To develop a quality assurance process for proton prostate therapy [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
To allow for future research of pathologic risk factors that may influence prognosis; this information will help us to attempt to characterize their presence in low and intermediate risk prostate cancer and their potential effect on outcomes [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
To compare an IMRT plan with the proton therapy radiation plan [ Time Frame: At 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	November 2010
Estimated Study Completion Date:	December 2021
Estimated Primary Completion Date:	December 2021 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Proton Radiation Hypofractionation 5 fractions (7.6 Gy(RBE) x 5)	Radiation: Proton Radiation Hypofractionation Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks Other Name: Particle Therapy
Active Comparator: Proton Radiation Standard Fractionation 44 fractions (1.8 Gy(RBE) x 44)	Radiation: Proton Radiation Standard Fractionation Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks Other Name: Particle Therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230866

Contacts

Contact: Angela Piper, MBA, BA

765-327-0344

angela.piper@pcgresearch.org

Locations

United States, Illinois
ProCure Proton Therapy Center	Recruiting
Warrenville, Illinois, United States, 60555
Contact: William Hartsell, MD 630-821-6400 william.hartsell@chi.procure.com
Contact: Corey Woods, RN,MS,CCRC 630-821-6397 corey.woods@chi.procure.com
Principal Investigator: William Hartsell, MD
United States, Oklahoma
ProCure Proton Therapy Center	Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Tisha Adams, MS, CCRC 405-773-6775 tisha.adams@okc.procure.com
Principal Investigator: Gary Larson, MD

Sponsors and Collaborators

Proton Collaborative Group

Investigators

Study Chair:

Carlos Vargas, MD

Proton Collaborative Group

More Information

No publications provided

Responsible Party:	Proton Collaborative Group
ClinicalTrials.gov Identifier:	NCT01230866 History of Changes
Other Study ID Numbers:	GU002-10
Study First Received:	October 27, 2010
Last Updated:	April 1, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:

Proton Radiation Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013