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Cardiovascular Care for Prostate Cancer

N/A

Recruiting

Led By Alicia Morgans, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years.

Be older than 18 years old

Must not have

Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.

Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months (from 4 weeks after adt initiation to the week 24 on-treatment visit)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program to assess and manage cardiovascular risk factors in prostate cancer patients starting hormone therapy. The goal is to create a standardized method for all patients at the Dana-Farber Cancer Institute

Who is the study for?

This trial is for individuals with prostate cancer who are beginning androgen deprivation therapy (ADT). It aims to help manage cardiovascular risks that may arise from their cancer treatment. Participants should be starting ADT soon or have started it recently.

What is being tested?

The study is testing a 'CV Care Program' designed to assess and manage heart health risks in patients undergoing ADT for prostate cancer. The goal is to see if this program can become a standard part of patient care at the Dana-Farber Cancer Institute.

What are the potential side effects?

Since the intervention involves assessment and management rather than medication, direct side effects are not expected as typically seen with drug trials. However, any changes made to manage CV risk could potentially have their own effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been on ADT therapy for prostate cancer for more than 12 weeks.

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I am not on ADT with chemotherapy, radioligand therapy, or any clinical trial treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months (from 4 weeks after adt initiation to the week 24 on-treatment visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months (from 4 weeks after adt initiation to the week 24 on-treatment visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months (from 4 weeks after adt initiation to the week 24 on-treatment visit) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant Retention Rate in CV CARE 2

Secondary study objectives

Proportion of Participants on Blood Pressure Medications in CV CARE

Proportion of Participants on Blood Pressure Medications in CV CARE 2

Proportion of Participants on Statin Medications in CV CARE

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CV Care Program 2Experimental Treatment1 Intervention

Study procedures will be conducted as follows: * Standard of care androgen deprivation therapy. * 4 week standard-of-care follow up visit in clinic with CV care education module completion. * 12-week standard-of-care prostate cancer care visit with oncologist. * 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members. * Participant feedback from surveys, exit-interviews, and possibly focus groups will be collected.

Group II: CV Care ProgramExperimental Treatment1 Intervention

Study procedures will be conducted as follows: * Standard of care androgen deprivation therapy. * 4 week standard-of-care follow up visit in clinic with CV care education module completion. * 12-week standard-of-care prostate cancer care visit with oncologist. * 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members. * The CV Care program will be revised through participant feedback from assessments, surveys, focus groups, and exit-interviews. The revised CV Care Program will be used in the next cohort.

0 / 3Eligibility criteria met