PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Phase 4Active Not RecruitingNCT06074510

Lantheus Medical Imaging274 enrolled

Overview

The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

274

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must have the ability to understand and sign an approved informed consent form (ICF) 2. Patients must have the ability to understand and comply with all protocol requirements 3. Patients must be ≥ 18 years of age 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5. Patients with life expectancy of at least 13 months as determined by the investigator 6. Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following: * 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL) * ISUP Grade Group 1 or 2 * \<50% biopsy cores positive (e.g., \<6 of 12 cores) Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging Exclusion Criteria: 1. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging) 2. Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy 3. Known hypersensitivity to the components of PYLARIFY or its analogs 4. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study 5. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

Locations (14)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Hoag Cancer Center

Irvine, California, United States

Tower Urology

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Emory University

Atlanta, Georgia, United States

University of Iowa Health Care

Iowa City, Iowa, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute Wayne State University

Detroit, Michigan, United States

BAMF Health

Grand Rapids, Michigan, United States

...and 4 more locations

Outcomes

Primary Outcomes

Detection rate

The proportion of participants with prostate cancer in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as assessed by pathology, or in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases, divided by the number of subjects who undergo a PYLARIFY PET scan

Time frame: Day 1

Secondary Outcomes

Change in intended patient clinical management

Intended medical management plan before and after PYLARIFY PET imaging

Time frame: Day 30

True detection rate

The percentage of participants with at least one true positive lesion identified on PYLARIFY PET imaging and confirmed by the truth standard. This measure includes patients in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as confirmed by pathology; or patients in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases as assessed by central readers and verified by the standard of truth.

Time frame: Day 1

Correct localization rate

The percentage of participants for whom there is a one-to-one correspondence on the same side between the location of at least one lesion outside of prostate capsule (extraprostatic extension, seminal vesicle invasion, pelvic lymph nodes, extrapelvic lymph nodes, extrapelvic bone or extrapelvic soft tissue lesion(s) identified on PYLARIFY PET/CT or PET/MR and the standard of truth.

Time frame: up to day 90

Positive predictive value of PYLARIFY

The percentage of participants who undergo PYLARIFY PET imaging that identifies a lesion or lesions outside of the prostate capsule and have an established standard of truth. Positive predictive value does not require a one-to-one correspondence by lesion location but requires that the lesion and standard of truth be within the same anatomic region, including prostatic, pelvic, extra-pelvic or distant lesions.

Time frame: up to day 90

Sensitivity of PYLARIFY

Sensitivity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

Time frame: up to day 90

Specificity of PYLARIFY

Specificity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

Time frame: up to day 90

Negative predictive value of PYLARIFY

Negative predictive value at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

Time frame: up to day 90

Number of participants with Adverse Events

Time frame: Day 1