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

NCT01230866 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: GU002-10
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Keywords

Proton Radiation Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  At 5 years post treatment completion +/- 90 days

Secondary Outcomes (1)

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

  At 6 months and 2 years post randomization

Study Arms (2)

Proton Radiation Hypofractionation

OTHER

5 fractions (7.6 Gy(RBE) x 5)

Radiation: Proton Radiation Hypofractionation

Proton Radiation Standard Fractionation

ACTIVE COMPARATOR

44 fractions (1.8 Gy(RBE) x 44)

Radiation: Proton Radiation Standard Fractionation

Interventions

Proton Radiation Hypofractionation RADIATION

Dose: 38 Gy(RBE); 7.6 GY(RBE) five days a week in 5 treatments over 1-2 weeks

Also known as: Particle Therapy

Proton Radiation Hypofractionation

Proton Radiation Standard Fractionation RADIATION

Dose: 79.2 GY(RBE); 1.8 GY(RBE) five days a week in 44 treatments over 8.5-9 weeks

Also known as: Particle Therapy

Proton Radiation Standard Fractionation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Proton Collaborative Group: lead

Study Sites (5)

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

Location

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555, United States

Location

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

Oklahoma Proton Center

Oklahoma City, Oklahoma, 73142, United States

Location

Hampton University Proton Therapy Institute

Hampton, Virginia, 23666, United States

Location

Related Publications (1)

• Toesca DAS, Hartsell WF, DeWees TA, Chang JH, Laughlin BS, Voss MM, Dodoo CA, Mohammed N, Keole SR, McGee LA, Gondi V, Sweeney PJ, Dorn P, Sinesi CC, Doh LS, Rich T, Vargas CE. Stereotactic Body Proton Therapy Versus Conventionally Fractionated Proton Therapy for Early Prostate Cancer: A Randomized, Controlled, Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1377-1385. doi: 10.1016/j.ijrobp.2024.05.014. Epub 2024 Jul 6.

  PMID: 38972465 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Carlos Vargas, MD

  Proton Collaborative Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: November 1, 2010
• Primary Completion (Estimated): December 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

US (5)