Hypofractionated Image-Guided Radiation Therapy In Treating Patients with Localized Prostate Cancer

This phase II trial studies how well hypofractionated image-guided radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may be an effective treatment for prostate cancer.

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the prostate
• Clinical stages T1a-T2b
• Prostate specific antigen (PSA) of less than 10 ng/ml
• Gleason score of 3+4 or lower
• The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer
• Signed study-specific consent form prior to registration

Exclusion Criteria

• Clinical stages T3-4 disease
• Gleason (4+3) or higher score
• PSA > 10 ng/ml
• History and/or clinical evidence of lymph node involvement (N1)
• History and/or clinical evidence of distant metastases (M1)
• Radical surgery for carcinoma of the prostate
• Previous chemotherapy or pelvic radiation therapy
• Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
• History of inflammatory bowel disease
• Major medical or psychiatric illness which, in the investigator’s opinion, would prevent completion of treatment and would interfere with follow up
• Androgen suppression therapy within past year; defined as: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or androgen blocker, not 5-alpha reductase inhibitor

PRIMARY OBJECTIVES:

I. Assess the incidence of grade 2 and 3+ genitourinary (GU) and gastrointestinal (GI) toxicity and self-reported quality of life data with image-guided radiation therapy in doses of 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

SECONDARY OBJECTIVES:

I. Assess biochemical, clinical, and pathologic control rates associated with the hypofractionated dose regimen.

II. Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.

OUTLINE:

Patients undergo 16 fractions of hypofractionated image-guided radiation therapy over 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years, and then annually for 3 years.

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Daniel Yeong-Jin Song

Primary ID J0859
Secondary IDs NCI-2010-02069, NA_00019393
Clinicaltrials.gov ID NCT00809991