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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01230866
• Other study ID #: GU002-10
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2010

Study information

• Verified date: May 2024
• Source: Proton Collaborative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Maryland Proton Treatment Center	Baltimore	Maryland
United States	Hampton University Proton Therapy Institute	Hampton	Virginia
United States	Oklahoma Proton Center	Oklahoma City	Oklahoma
United States	Mayo Clinic Cancer Center	Phoenix	Arizona
United States	Northwestern Medicine Chicago Proton Center	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Proton Collaborative Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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