Recruiting
Phase 1

Stereotactic Radiosurgery

Sponsor:

San Diego Radiosurgery

Code:

NCT00969202

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Radiosurgery using the Novalis Tx

Study Details

Brief summary:

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.

Conditions

Prostate Cancer

Study ID

NCT00969202

Start date

Aug, 2009

Status verified date

Nov, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stereotactic Radiosurgery using NovalisTx

Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.

Interventions

Stereotactic Radiosurgery using the Novalis Tx

Five treatments given every other day.

Primary outcome measure

  • PSA decline measured through laboratory testing. [ Time Frame: One month following radiosurgery through 5 year follow up ]

Central Contacts and Locations

Central contacts

Jennifer Joiner

760-739-3185Jennifer.joiner@palomarhealth.org

Jeremy Legg

615-920-1282jlegg@Allianceoncology.com

Locations

San Diego Radiosurgery at Palomar Medical Center

Recruiting

Escondido, California, United States, 92025

Contacts

Jennifer Joiner

760-739-3185Jennifer.joiner@palomarhealth.org

Principal Investigator:

P. Brian Volpp, MD, MPH

More Information

Sponsor

San Diego Radiosurgery

Last update posted

Nov 18, 2015

Last verified

Nov, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego Radiosurgery on 2015-11-18.