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Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiation
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Localized Prostate Cancer, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy

Arm Description

Radiation Therapy

Outcomes

Primary Outcome Measures

the maximum tolerated dose of HRT
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.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2012
Last Updated
August 25, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01677845
Brief Title
Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer
Official Title
Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
PI no longer with the institution
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Localized Prostate Cancer, Radiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Therapy
Arm Type
Experimental
Arm Description
Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
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 Outcome Measure Information:
Title
the maximum tolerated dose of HRT
Description
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.
Time Frame
30 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J Sanfilippo, MD
Organizational Affiliation
NYU Langone Medical Center, Departement of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

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