PRISM: Patient Experiences With PET Imaging in Prostate Cancer

NCT ID: NCT06523777

Last Updated: 2025-09-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-25

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine patient experiences, health-related quality of life, and decision-making associated with PET imaging for prostate cancer. In particular, Prostate Specific Membrane Antigen (PSMA) PET, a new and more sensitive form of imaging that can help identify metastatic cancer earlier and more reliably.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to measure health related quality of life among patients with prostate cancer who are undergoing prostate specific membrane positron emission tomography (PSMA-PET) imaging. This will be assessed in four domains: cancer related anxiety, decisional conflict, health related quality of life (physical functioning) and health preferences.

The secondary objective is to conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging.

Study Design Investigators will conduct a longitudinal explanatory sequential mixed methods study consisting of two phases. In the first phase, serial quantitative psychological (anxiety, uncertainty) and HRQoL survey data from patients undergoing PET imaging in routine clinical care will be collected. In the second phase, a subset of patients from phase 1 who have completed initial surveys will be recruited and conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging.

Patient clinical and sociodemographic data will be collected through automated extraction from the medical record (EPIC) into the REDcap database through collaboration with JDAT. For fields that are not populated via automated methods we will manually enter information via abstraction of the patient's medical record (EPIC).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Documented diagnosis of prostate cancer
* Scheduled for their FIRST PSMA PET scan for prostate cancer
* English-speaking
* Willing and able to complete 4 surveys electronically or on paper at 3 timepoints (within 1 month after PET scan, 3-6 months, 12 months)
* Able to use mobile device (smartphone or tablet) or computer with web access to complete study surveys or able to complete paper surveys

Exclusion Criteria

* Lack of access to a mobile device (smartphone or tablet) or computer with web access or unable to receive surveys by mail.
* Unable to give consent and be enrolled
* PET scan is being conducted within a clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Leapman, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale New Haven Health Bridgeport Hospital - Park Ave Medical Center

Bridgeport, Connecticut, United States

Site Status RECRUITING

Griffin Hospital

Derby, Connecticut, United States

Site Status RECRUITING

Yale New Haven Health Greenwich Hospital

Greenwich, Connecticut, United States

Site Status RECRUITING

Radiology and Biomedical Imaging - New Haven - Smilow Cancer Hospital (North Pavilion):

New Haven, Connecticut, United States

Site Status RECRUITING

Saint Raphael's Radiology and Biomedical Imaging, Basement Location.

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Yale New Haven Health Lawrence & Memorial Hospital

New London, Connecticut, United States

Site Status RECRUITING

Yale New Haven Health Westerly Hospital

Westerly, Rhode Island, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael S Leapman, MD

Role: CONTACT

203-785-3128

Sarah Linsky, MPH

Role: CONTACT

475.375.6129

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01CA281959-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000037284

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Monitoring Patient Prostate Health Post Therapy
NCT07115914 NOT_YET_RECRUITING NA
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
NCT03181867 ENROLLING_BY_INVITATION PHASE2
PSMA PET Imaging of Recurrent Prostate Cancer
NCT03204123 ACTIVE_NOT_RECRUITING PHASE2
68Ga-P3 PET/CT Imaging in Prostate
NCT05940259 RECRUITING NA