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Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage


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

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Trial Information

Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of the prostate

- Gleason score ≤ 6 and low volume Gleason 7 (3+4)

- PSA < 10

- Clinical Stage of T2a or less

- Ability to understand and the willingness to sign a written informed consent
document

Exclusion Criteria:

- Prior radiation treatment for prostate cancer

- Gleason score > 7

- PSA > 10

- Clinical Stage of T2b or greater

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PSA decline measured through laboratory testing.

Outcome Time Frame:

One month following radiosurgery through 5 year follow up

Safety Issue:

No

Principal Investigator

P. Brian Volpp, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

SDRS0001

NCT ID:

NCT00969202

Start Date:

August 2009

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Cancer of the Prostate
  • Prostate Tumor
  • Novalis Tx
  • Novalis
  • Stereotactic Radiosurgery
  • Radiosurgery
  • Radiation
  • Prostatic Neoplasms

Name

Location
San Diego Radiosurgery at Palomar Medical Center Escondido, California  92025