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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proton Radiation Hypofractionation

5 fractions (7.6 Gy(RBE) x 5)

Group Type OTHER

Proton Radiation Hypofractionation

Intervention Type RADIATION

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

Proton Radiation Standard Fractionation

44 fractions (1.8 Gy(RBE) x 44)

Group Type ACTIVE_COMPARATOR

Proton Radiation Standard Fractionation

Intervention Type RADIATION

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

Interventions

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Proton Radiation Hypofractionation

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

Intervention Type 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

Intervention Type RADIATION

Other Intervention Names

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Particle Therapy Particle Therapy

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No