Stereotactic Hypofractionated Radiosurgery for Early Stag... | NCT00969202

Studies
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

NCT00969202

Sponsor

San Diego Radiosurgery

Status

Unknown status

Last Update Posted

Nov 18, 2015Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Prostate Cancer

Interventions

Stereotactic Radiosurgery using the Novalis Tx

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Aug 28, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2015

Last Update Posted Date

Nov 18, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stereotactic Radiosurgery using NovalisTx	Experimental	Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.	Radiation: Stereotactic Radiosurgery using the Novalis Tx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stereotactic Radiosurgery using the Novalis Tx	Radiation	Five treatments given every other day.	Stereotactic Radiosurgery using NovalisTx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA decline measured through laboratory testing.		One month following radiosurgery through 5 year follow up

Secondary Outcomes

Measure	Description	Time Frame
Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.		One month following radiosurgery through 5 years follow up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer Joiner	Contact	760-739-3185		Jennifer.joiner@palomarhealth.org
Jeremy Legg	Contact	615-920-1282		jlegg@Allianceoncology.com

Overall Officials

Name	Affiliation	Role
P. Brian Volpp, MD, MPH	San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Diego Radiosurgery at Palomar Medical Center	Recruiting	Escondido	California	92025	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided