Clinical trial NCT01230866: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Proton Radiation Prostate Cancer
Lead sponsor: Proton Collaborative Group
Sponsor class: NETWORK
First posted: 2010-10-29
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 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.
timeFrame: At 5 years post treatment completion +/- 90 days
Secondary outcomes:
measure: To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
timeFrame: At 6 months and 2 years post randomization
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center
state: Arizona
city: Warrenville
country: United States
facility: Northwestern Medicine Chicago Proton Center
state: Illinois
city: Baltimore
country: United States
facility: Maryland Proton Treatment Center
state: Maryland
city: Oklahoma City
country: United States
facility: Oklahoma Proton Center
state: Oklahoma
city: Hampton
country: United States
facility: Hampton University Proton Therapy Institute
state: Virginia
Study officials:
affiliation: Proton Collaborative Group
name: Carlos Vargas, MD
role: STUDY_CHAIR
References: