Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment radiation
Phase phase 1
Sponsor New York University School of Medicine
Start date May 2012
End date February 2017
Trial size 10 participants
Trial identifier NCT01677845, S12-00867

Summary

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.

United States New York
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Radiation Therapy
radiation
Dose Level 1: 54 Gy; 3 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions; Dose Level 2: 55.8 Gy; 3.1 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions; Dose Level 3: 57.6 Gy; 3.2 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions.

Primary Outcomes

Measure
the maximum tolerated dose of HRT
time frame: 30 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

Official title Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized Prostate Cancer
Principal investigator Nicholas J Sanfilippo, MD
Description Dose escalation will be as follows: There will be 3 cohorts consisting of 3 patients each. All patients will receive 18 fractions of HRT over the course of 6 weeks (3 fractions per week). Dose level I will be 54Gy (3 Gy per fraction), dose level II will be 55.8 Gy (3.1Gy per fraction), dose level III will be 57.6 Gy (3.2 Gy per fraction). After accrual of dose level I, all patients will be observed for a minimum of two weeks after completion of radiation treatments, for assessment of toxicity, before the dose can be escalated for the next cohort. After dose level II, patients will be observed for 6 months before enrolling patients on dose level III. All patients will be seen weekly by their radiation oncologist during radiation therapy. Any observations regarding radiation reactions will be recorded.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.