Hypo-Fractionated Radiation Therapy for Localized Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2012 |
| End Date: | July 2022 |
| Contact: | Nicholas Sanpilippo, MD |
| Email: | nichols.sanfilippo@nyumc.org |
| Phone: | 212-731-5003 |
Phase I Study of Hypo-Fractionated Radiation Therapy (HRT) for Localized Prostate Cancer
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10016
Principal Investigator: Nicholas J. Sanfilippo, M.D.
Phone: 212-731-5041
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