Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01677845
• Other study ID #: 12-00867
• Status: Terminated
• Phase: Phase 1
• First received: August 30, 2012
• Last updated: August 25, 2017
• Start date: May 2012
• Est. completion date: August 25, 2017

Study information

• Verified date: August 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 25, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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