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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535987
• Other study ID #: UPCC 18817
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: October 19, 2019

Study information

• Verified date: June 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 51 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects who successfully complete Rb-82 myocardial PET Imaging assessments		12-18 months