Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

Stopped early · Phase 1

Conditions studied: Prostate Cancer

In brief

The aim of this study is to determine the maximum tolerated dose of hypo-fractionated radiation therapy and the toxicity of the treatment program. Eligible patients with stage T1-2c prostate cancer who sign consent will be enrolled to this phase I dose escalation trial and be treated with hypo-fractionated radiation therapy (HRT). Dose escalation will be as follows: There will be 3 cohorts consisting of 3 patients each.

Key facts

Study ID

NCT01677845

Run by

NYU Langone Health

People needed

9

Starts

2012-05-01

Expected to finish

2017-08-25

Last updated by the study team

2017-08-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
• Clinical stage T1-2c (AJCC 6th edition)
• Gleason <6 and PSA <10 ng/mL
• Gleason =7 and/or PSA 10-20 ng/mL provided <34% of core biopsies are positive for carcinoma
• PSA < 20 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy.
• Zubrod performance status 0-1
• Age ≥ 18
• Patient must sign study specific informed consent prior to randomization.

You may not qualify if…

• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
• Evidence of distant metastases
• Regional lymph node involvement
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Prior androgen deprivation therapy (ADT)
• Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer

Where it is running

• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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