Pilot Cohort Study of Rb-82 Myocardial PET Imaging to Evaluate Coronary Microvascular Dysfunction in Men With Prostate Cancer Receiving Androgen-Deprivation Therapy

NCT ID: NCT03535987

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-19

Study Completion Date

2019-10-19

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

To determine the feasibility of using myocardial PET imaging

myocardial PET imaging

Intervention Type 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

Interventions

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myocardial PET imaging

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

51 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivek Narayan, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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UPCC 18817

Identifier Type: -

Identifier Source: org_study_id

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