Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

NCT01677845 | Terminated Phase 1 DMC

• 1 other identifier: 12-00867
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Localized Prostate Cancer; Radiation

Outcome Measures

Primary Outcomes (1)

• 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.

  30 weeks

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Radiation Therapy

Radiation: Radiation

Interventions

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.

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Nicholas J Sanfilippo, MD

  NYU Langone Medical Center, Departement of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: August 25, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

US (1)