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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the maximum tolerated dose of HRT

Outcome Description:

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.

Outcome Time Frame:

30 weeks

Safety Issue:

Yes

Principal Investigator

Nicholas J Sanfilippo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU Langone Medical Center, Departement of Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

S12-00867

NCT ID:

NCT01677845

Start Date:

May 2012

Completion Date:

July 2022

Related Keywords:

  • Prostate Cancer
  • Localized Prostate Cancer
  • Radiation
  • Prostatic Neoplasms

Name

Location
NYU Langone Medical Center New York, New York  10016