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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Daniel Yeong-Jin Song
Phone: 410-502-5875
Email: dsong2@jhmi.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Daniel Yeong-Jin Song

Trial IDs

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