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Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate


Phase 1/Phase 2
50 Years
90 Years
Open (Enrolling)
Male
Prostatic Neoplasm

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Trial Information

Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate


External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to
deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo
Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1
to 2 week period of time suggest that outcomes may be equal or superior to standard
approaches. These data, combined with markedly improved convenience for patients, make
radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this
study is to offer a radiosurgical option to patients within the Sharp system under the
umbrella of an IRB-approved study.


Inclusion Criteria:



- Male with any age (typically 50 to 70 years old) with a low risk disease. This is
defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA
of less than 10. We will also include patients with Gleason's score of 3+4=7 if
there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate
dimension.

Exclusion Criteria:

- Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8,
9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

acute and late toxicity to the GU and GI systems

Outcome Description:

acute and late toxicity to the GU and GI systems based on the RTOG definitions will be compared to those of standard radiation therapy.

Outcome Time Frame:

1 year follow-up

Safety Issue:

Yes

Principal Investigator

Geoffrey Weinstein, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sharp HealthCare

Authority:

United States: Institutional Review Board

Study ID:

101091

NCT ID:

NCT01540994

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Prostatic Neoplasm
  • Neoplasms
  • Urogenital neoplasm
  • Genital neoplasms, male
  • Neoplasms
  • Prostatic Neoplasms

Name

Location
Sharp Memorial Hospital San Diego, California  92123