Clinical trial NCT03756077: A Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer
Official title: A Prospective Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
PET/MR
PET/CT
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Central China

Brief summary: According to the latest data from the China National Cancer Center, prostate cancer has become the most common tumor in the urinary system since 2008. However, conventional imaging techniques including transrectal ultrasound , computed tomography and bone scintigraphy are not sensitive or specific. About 40% of resectable lesions cannot be detected by these techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new novel positron tracer has shown to be effective to detect primary lesions, recurrent and metastatic lesions of prostate cancer. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with prostate cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent \[F-18\]fluorodeoxyglucose to image patients with or suspected of prostate cancer, the aim is to explore the value of hybrid PET/MR and PET/CT in prostate cancer.

Detailed description: According to the latest data from the China National Cancer Center, prostate cancer has become the most common tumor in the urinary system since 2008. However, conventional imaging techniques including transrectal ultrasound , computed tomography and bone scintigraphy are not sensitive or specific. About 40% of resectable lesions cannot be detected by these techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new novel positron tracer has shown to be effective to detect primary lesions, recurrence and metastatic lesions of prostate cancer. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR, and PET/CT with prostate cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent \[F-18\]fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with prostate cancer, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging and determining treatment plan prior to treatment; for the patients with a history of prostate cancer, the aim is to evaluate the value of integrated PET/MR and PET/CT for treatment response assessment, detection of recurrences and metastatic lesions.

Eligibility criteria: Inclusion Criteria:

* Patients suspected of or diagnosed with prostate cancer

Exclusion Criteria:

* Acute systemic diseases and electrolyte disorders
* Patients with known malignancy in other organs
* Patients with severe claustrophobia or unstable vital sigh
* Other serious comorbidities evaluated by primary investigator

Primary outcomes:
measure: Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for initial diagnosis and staging
timeFrame: up to 2 years
Secondary outcomes:
measure: Sensitivity and specificity of 68Ga- PSMA, 18F-FDG PET/MR, PET/CT for recurrence detection
timeFrame: up to 2 years
measure: Sensitivity of 68Ga-PSMA PET/MR, PET/CT for different PSA levels, different lesion sites
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Xiaoli Lan
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaoli Lan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qin C, Gai Y, Liu Q, Ruan W, Liu F, Hu F, Zhang X, Lan X. Optimized Application of 68Ga-Prostate-Specific Membrane Antigen-617 Whole-Body PET/CT and Pelvic PET/MR in Prostate Cancer Initial Diagnosis and Staging. Front Med (Lausanne). 2021 May 13;8:657619. doi: 10.3389/fmed.2021.657619. eCollection 2021.