Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer

NYU Langone Health

Status and phase

Terminated

Phase 1

Conditions

Prostate Cancer

Treatments

Radiation: Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01677845

12-00867

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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