PRISM: Patient Experiences With PET Imaging in Prostate Cancer

NCT06523777 | Recruiting

• 2 other identifiers: 20000372841R01CA281959-01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 7

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Change in Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

  An 18-item instrument assessing frequency of anxiety in response to prostate cancer with 4 Likert responses ranging from 0 (not at all) to 3 (often); total score range 0 to 54). Higher scores indicate more anxiety.

  baseline, 3-6 months, and 12 months

• Change in Decisional Conflict Scale (DCS)

  A 16-item instrument using a 5-point Likert scale, ranging from 0 (strongly agree)-4 (strongly disagree), that has been widely applied to understand decision-making in prostate cancer. Higher scores indicate greater degrees of decisional conflict. DCS subscales include patient perceptions of uncertainty in choosing among treatment options, the contribution of modifiable factors (e.g., feeling uninformed), and effectiveness of decision-making (e.g., satisfaction with the choice). Total and subscale scores range from 0 to 100.

  baseline, 3-6 months, and 12 months

• Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)

  A 26 item prostate cancer specific health-related quality of life (HRQOL) questionnaire assessing urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.

  baseline, 3-6 months, and 12 months

• Change in EuroQol-5 Dimension (EQ-5D)

  The instrument assesses five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D values can be converted to calculate health utilities that will be used for estimation of quality adjusted life years in decision analytic modeling. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales.

  baseline, 3-6 months, and 12 months

Secondary Outcomes (1)

• Qualitative interviews on patient experiences and perspectives on PET imaging.

  baseline, 3-6 months, and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Yale New Haven Health Bridgeport Hospital - Park Ave Medical Center

Bridgeport, Connecticut, 06611, United States

RECRUITING

Griffin Hospital

Derby, Connecticut, 06418, United States

RECRUITING

Yale New Haven Health Greenwich Hospital

Greenwich, Connecticut, 06830, United States

RECRUITING

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

New Haven, Connecticut, 06520, United States

RECRUITING

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

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Yale New Haven Health Lawrence & Memorial Hospital

New London, Connecticut, 06320, United States

RECRUITING

Yale New Haven Health Westerly Hospital

Westerly, Rhode Island, 02891, United States

RECRUITING

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

• Michael Leapman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael S Leapman, MD

CONTACT

203-785-3128; michael.leapman@yale.edu

Sarah Linsky, MPH

CONTACT

475.375.6129; sarah.linsky@yale.edu

Study Design

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

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)