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

• ClinicalTrials.gov Identifier: NCT01230866
• Recruitment Status: Active, not recruiting
• First Posted: October 29, 2010
• Last Update Posted: April 4, 2023
• Sponsor: Proton Collaborative Group
• Information provided by (Responsible Party): Proton Collaborative Group

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Radiation: Proton Radiation Hypofractionation; Radiation: Proton Radiation Standard Fractionation	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: November 2010
• Estimated Primary Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: At 5 years post treatment completion +/- 90 days ]
   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 :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Arizona

Mayo Clinic Cancer Center

Phoenix, Arizona, United States, 85054

United States, Illinois

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, United States, 60555

United States, Maryland

Maryland Proton Treatment Center

Baltimore, Maryland, United States, 21201

United States, Oklahoma

Oklahoma Proton Center

Oklahoma City, Oklahoma, United States, 73142

United States, Virginia

Hampton University Proton Therapy Institute

Hampton, Virginia, United States, 23666

Sponsors and Collaborators

Proton Collaborative Group

Investigators

• Study Chair: Carlos Vargas, MD; Proton Collaborative Group

More Information

• Responsible Party: Proton Collaborative Group
• ClinicalTrials.gov Identifier: NCT01230866
• Other Study ID Numbers: GU002-10
• First Posted: October 29, 2010
• Last Update Posted: April 4, 2023
• Last Verified: April 2023

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; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases