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Completed

NCT Number: NCT03535987

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

51 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. number of subjects who successfully complete Rb-82 myocardial PET Imaging assessments

    Time frame: 12-18 months

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 24, 2018
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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