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

NCT03535987 | Completed DMC FDA Device

• 1 other identifier: UPCC 18817
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  12-18 months

Study Arms (1)

Observational

To determine the feasibility of using myocardial PET imaging

Device: myocardial PET imaging

Interventions

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

Observational

Eligibility Criteria

• Age: 51 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Vivek Narayan, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: January 19, 2018
• Primary Completion: April 19, 2019
• Study Completion: October 19, 2019
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

US (1)