Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Eva... | NCT03535987

Status Module

Record Verification Date

Nov 2024

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

Jan 19, 2018Actual

Primary Completion Date

Apr 19, 2019Actual

Completion Date

Oct 19, 2019Actual

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

May 14, 2018

First Posted Date

May 24, 2018Actual

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 15, 2024

Last Update Posted Date

Nov 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

To determine the feasibility of using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen- deprivation therapy with external beam radiation therapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		To determine the feasibility of using myocardial PET imaging	Device: myocardial PET imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
myocardial PET imaging	Device	using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen-deprivation therapy with external beam radiation therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of subjects who successfully complete Rb-82 myocardial PET Imaging assessments		12-18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Either clinically localized prostate cancer or biochemically-recurrent prostate cancer patients who are planned for at least 6 months ADT with a GnRH agonist and curative-intent radiation therapy per their oncologic providers.
Over 50 years of age. Calculated 10-year Framingham General Cardiovascular Risk Score of ≥10% at the time of planned initiation of ADT.
Patients must be able to read and understand English.
Participants must sign the informed consent form.

Exclusion Criteria:

Prior treatment with GnRH agonist therapy.
History of active asthma or other reactive airway disease.
Ischemic cardiac event (myocardial infarction, unstable angina) within the preceding 6 months.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen-deprivation therapy with external beam radiation therapy

Minimum Age

51 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

men with clinically-localized or biochemically recurrent prostate cancer planned for curative-intent external beam radiation therapy with concomitant ADT for a duration of at least 6 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivek Narayan, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Oct 11, 2017	Jun 15, 2020

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases