The AIM Study: Assessing the Impact of Margin Reduction | NCT00754000

Studies
The AIM Study: Assessing the Impact of Margin Reduction

NCT00754000

Sponsor

Varian, a Siemens Healthineers Company

Status

Completed

Last Update Posted

Apr 30, 2012Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Observation

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Not provided

Completion Date

Sep 2009Actual

First Submitted Date

Sep 15, 2008

First Submission Date that Met QC Criteria

Sep 15, 2008

First Posted Date

Sep 17, 2008Estimated

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

Apr 27, 2012

Last Update Posted Date

Apr 30, 2012Estimated

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

This study will observe patients who receive external beam radiation for prostate cancer. These patients will be localized and tracked (targeted) with the Calypso 4D Localization System. These patients will have a uniform treatment plan with reduced PTVs (prostate treatment volume) and will be assessed at multiple time points for quality of life and side effects related to radiation therapy.

Detailed Description

EPIC surveys and adverse events recorded and categorized using the CTCAE v3.0 will be collected and summary statistics performed. The patient's individual tracking graphs will be evaluated for motion type and frequency.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		All patients in study	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	AE monitoring and EPIC QOL survey	Cohort 1	EPIC survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate patient quality of life using Expanded Prostate Cancer Index Composite (EPIC) for evaluation of the QOL		2 year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Collection of patient tracking data from the Calypso 4D Localization System		9 weeks
Record the number of interventions patients receive during radiation delivery to maintain the target within the treatment plan		9 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are planning to receive external beam radiation of prostate
Patients who are to be implanted with Beacon Transponders in the prostate
18 years of age or older.
Histologically confirmed diagnosis of prostate cancer.
Ability to comply with study visit schedule.
Signed informed consent form.

Exclusion Criteria:

Any patients who have received other investigational therapy within the last 60 days are excluded.
Individuals that have previously been implanted with permanent Beacon transponders are excluded.
Patients that have any prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
Any other medical or other condition that would, at the discretion of the investigator, preclude the individual from participation in a clinical study.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Males diagnosed with prostate cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Constantine Mantz, MD	GenesisCare USA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
21st Century Oncology - Scottsdale		Scottsdale	Arizona	85251	United States
21st Century Oncology - Santa Monica

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Pollack A. "The Prostate" in Radiation Oncology: Rationale, Techniques and Results edited by Cox and Ang. Mosby 2003 p 630.
3967982	Background	Hanks GE, Leibel SA, Krall JM, Kramer S. Patterns of care studies: dose-response observations for local control of adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):153-7. doi: 10.1016/0360-3016(85)90374-8.
12128109

Type	Date	Date Unknown
Release	Jul 20, 2015
Reset	Aug 17, 2015
Release	Oct 13, 2015
Reset	Nov 13, 2015

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 20, 2015			Aug 17, 2015
Oct 13, 2015

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

ID	Term
D008722	Methods
D008919	Investigative Techniques