Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

NCT ID: NCT01677845

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2017-08-25

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Therapy

Radiation Therapy

Group Type: EXPERIMENTAL

Radiation

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas J Sanfilippo, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center, Departement of Radiation Oncology

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

12-00867

Identifier Type: -

Identifier Source: org_study_id