Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06523777

PRISM: Patient Experiences With PET Imaging in Prostate Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Health Bridgeport Hospital - Park Ave Medical Center, Bridgeport, Connecticut, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: baseline, 3-6 months, and 12 months

    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.

  2. Change in Decisional Conflict Scale (DCS)

    Time frame: baseline, 3-6 months, and 12 months

    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.

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

    Time frame: baseline, 3-6 months, and 12 months

    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.

  4. Change in EuroQol-5 Dimension (EQ-5D)

    Time frame: baseline, 3-6 months, and 12 months

    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.

Secondary outcomes

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

    Time frame: baseline, 3-6 months, and 12 months

    Longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging to assess emergent themes. A subset of patients will be invited to participate in parallel in depth focused interviews occurring at three time points matching those of the surveys. Sample size will be dynamic and assessed based on emergent themes that become apparent during coding and analysis of interviews.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Optimizing Prostate Cancer Care: Integrating Risks, Benefits and Patient Experiences in the New Era of Molecular Imaging

Acronym: PRISM

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 26, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.