Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

August 25, 2017 updated by: NYU Langone Health

Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized Prostate Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation Therapy
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the maximum tolerated dose of HRT
Time Frame: 30 weeks
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.
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Nicholas J Sanfilippo, MD, NYU Langone Medical Center, Departement of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-00867

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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