Clinical trial NCT06523777: PRISM: Patient Experiences With PET Imaging in Prostate Cancer
Official title: Optimizing Prostate Cancer Care: Integrating Risks, Benefits and Patient Experiences in the New Era of Molecular Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with documented diagnosis of prostate cancer undergoing PSMA-PET imaging, including participants along the disease spectrum (all grades, stages, and indications for imaging). Participants will be identified and screened from all referrals to PET imaging and contacted by a study coordinator.

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
timeFrame: baseline, 3-6 months, and 12 months
measure: Change in Decisional Conflict Scale (DCS)
timeFrame: baseline, 3-6 months, and 12 months
measure: Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
timeFrame: baseline, 3-6 months, and 12 months
measure: Change in EuroQol-5 Dimension (EQ-5D)
timeFrame: baseline, 3-6 months, and 12 months
Secondary outcomes:
measure: Qualitative interviews on patient experiences and perspectives on PET imaging.
timeFrame: baseline, 3-6 months, and 12 months
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Yale New Haven Health Bridgeport Hospital - Park Ave Medical Center
state: Connecticut
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
city: Greenwich
country: United States
facility: Yale New Haven Health Greenwich Hospital
state: Connecticut
city: New Haven
country: United States
facility: Radiology and Biomedical Imaging - New Haven - Smilow Cancer Hospital (North Pavilion):
state: Connecticut
city: New Haven
country: United States
facility: Saint Raphael's Radiology and Biomedical Imaging, Basement Location.
state: Connecticut
city: New London
country: United States
facility: Yale New Haven Health Lawrence & Memorial Hospital
state: Connecticut
city: Westerly
country: United States
facility: Yale New Haven Health Westerly Hospital
state: Rhode Island
Study officials:
affiliation: Yale University
name: Michael Leapman, MD
role: PRINCIPAL_INVESTIGATOR
References: