CClinicalTrials.gg
Status unknownNCT00969202Updated Nov 18, 2015

Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

A Phase 1 interventional study of Stereotactic Radiosurgery using the Novalis Tx in Prostate Cancer, sponsored by San Diego Radiosurgery. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-11-18.

Sponsored by San Diego Radiosurgery · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
  • Cancer of the Prostate
  • Prostate Tumor
  • Novalis Tx
  • Novalis
  • Stereotactic Radiosurgery
  • Radiosurgery
  • Radiation
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's planned enrollment of 50 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with San Diego Radiosurgery as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Prior radiation treatment for prostate cancer
  • Gleason score > 7
  • PSA > 10
  • Clinical Stage of T2b or greater
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Stereotactic Radiosurgery using NovalisTx

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

    Radiation: Stereotactic Radiosurgery using the Novalis Tx

Interventions

  • RadiationStereotactic Radiosurgery using the Novalis Tx

    Five treatments given every other day.

    Also known as: Novalis Tx, Novalis

06

What researchers measure

Primary outcomes

  1. PSA decline measured through laboratory testing.

    Time frame: One month following radiosurgery through 5 year follow up

Secondary outcomes

  1. Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.

    Time frame: One month following radiosurgery through 5 years follow up.

07

Study locations

1 of 1 sites recruiting
  • San Diego Radiosurgery at Palomar Medical Center
    Escondido, California 92025, United States
    • Jennifer Joiner · Contact · Jennifer.joiner@palomarhealth.org · 760-739-3185
    • Lori A Coleman, MD · Sub investigator
    • P. Brian Volpp, MD, MPH · Principal investigator
    • Kelly D Dewitt, MD · Sub investigator
    • Barry Uhl, MD · Sub investigator
    • Geoffrey Weinstein, MD · Sub investigator
    • Phillip Zentner, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00969202
Lead sponsor
San Diego Radiosurgery
Responsible party
Sponsor
First posted
Sep 1, 2009
Start date
Aug 2009
Primary completion
Aug 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Nov 18, 2015

Study contacts

Jennifer Joiner
Contact
Jennifer.joiner@palomarhealth.org
760-739-3185
Jeremy Legg
Contact
jlegg@Allianceoncology.com
615-920-1282
P. Brian Volpp, MD, MPH
principal investigator · San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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