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.
- 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
- 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
Locations & Contacts
Contact: Daniel Yeong-Jin Song
Trial Objectives and Outline
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).
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.
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.
Trial Phase & Type
Johns Hopkins University / Sidney Kimmel Cancer Center
Daniel Yeong-Jin Song
Secondary IDs NCI-2010-02069, NA_00019393
Clinicaltrials.gov ID NCT00809991