Suspended

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

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What is being tested

Radiation

Radiation
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorNYU Langone Health
Last updated: August 28, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01677845
Principal SponsorNYU Langone Health
Last updated: August 28, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

8 inclusion criteria required to participate
Age >= 18
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
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7 exclusion criteria prevent from participating
Evidence of distant metastases
Previous or concurrent cytotoxic chemotherapy for prostate cancer
Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Radiation Therapy

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

NYU Langone Medical Center

New York, United StatesOpen NYU Langone Medical Center in Google Maps
SuspendedOne Study Center