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Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

This study is currently recruiting participants.
Verified January 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01677845
First received: August 30, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Radiation: Radiation
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • the maximum tolerated dose of HRT [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: May 2012
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677845

Contacts
Contact: Michelle Malanga 212-731-5335 michelle.malanga@nyumc.org

Locations
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Nicholas J Sanfilippo, M.D.     212-731-5041        
Principal Investigator: Nicholas J. Sanfilippo, M.D.            
Sub-Investigator: Herbert Lepor, M.D.            
Sub-Investigator: Samit Taneja, M.D.            
Sub-Investigator: William Huang, M.D.            
Sub-Investigator: Silvia C Formenti, M.D.            
Sub-Investigator: Barry Rosenstein, Ph.D.            
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Nicholas J Sanfilippo, M.D. NYU Langone Medical Center, Departement of Radiation Oncology
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01677845     History of Changes
Other Study ID Numbers: S12-00867
Study First Received: August 30, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Localized Prostate Cancer
Radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013