Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients

Prostatic Neoplasms Clinical Trial

Official title:

Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790968
• Other study ID #: REK 50719
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Norwegian University of Science and Technology
• Contact: Tone Frost Bathen, prof
• Phone: 95021097
• Email: tone.f.bathen[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment. Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method to confirm lymph node metastases is by histologic examination of the resected lymph nodes. Ideally, one should be able to detect lymph node metastases prior to treatment. Then, the treatment could be better adjusted to each patient. Imaging methods such as prostate specific membrane antigen positron emission tomography (PSMA-PET) can possibly aid the detection of lymph node metastases. In this study, the investigators want to test whether PSMA-PET or a combination of PSMA-PET and MRI (magnetic resonance imaging) can improve staging of lymph nodes before treatment.

Description:

High-risk prostate cancer patients have a high probability for lymph node metastases in the pelvic region. The lymph node status is an important prognostic factor in determining the risk of later relapses and a factor in treatment planning. Lymph node metastases outside the pelvis usually signify systemic treatment not amendable for curative treatment. High-risk prostate cancer patients are treated by radiotherapy or surgical resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method for confirming lymph node metastases is by bilateral pelvic lymph node dissection during surgical treatment, and subsequent histologic examination. However, todays state-of-the art methods for the detection of lymph node metastases prior to treatment are clearly inadequate. Detection of lymph node metastases is crucial for determining whether the patient (i) is a candidate for localized treatment and, if so, (ii) optimizing the extent of the lymph node dissection / radiation field for localized treatment. Non-standard imaging methods such as prostate specific membrane antigen (PSMA)-PET-imaging have been shown to be able to aid in the detection of lymph node metastases. The purpose of this study is to test whether PSMA-PET or a combination of PSMA-PET and MRI can improve the sensitivity and specificity for pre-treatment lymph node staging in order to reduce both over- and undertreatment of high-risk prostate cancer patients. In this multi-centre study, at least 80 patients with high-grade prostate cancer (according to NCNN Guidelines, v 2.2022) will be examined with PSMA PET/MRI and PET/CT. Study recruitment will continue until 60 patients have received radial prostatectomy with extended pelvic lymph node dissection (ePLND) (surgery cohort) and 20 patients have been treated with radiotherapy to the prostate and pelvic lymph nodes (radiotherapy cohort). After the PET examinations, all patients will receive standard treatment and follow-up, which is determined by national guidelines and the patient's treating urologist and/or oncologist. Imaging data will be analyzed by radiologists and nuclear medicine physicians in collaboration. The imaging findings in the surgery cohort will be compared to the histology outcome after ePLND to assess the sensitivity and specificity for detection of lymph node involvement with PSMA PET/MRI. The data from the radiotherapy cohort will be used to assess the feasibility of PSMA PET/MRI-based radiotherapy planning. Advanced image processing and analysis methodology including the use of artificial intelligence will also be applied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion criteria (surgery cohort):

• High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group = 4

Inclusion criteria (radiotherapy cohort):

• High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group = 4

Exclusion criteria (surgery and radiotherapy cohort):

• Prior history of any other cancer the last 5 years excluding basal cell carcinoma
• Proven metastases in bones or other distant metastases
• General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
• Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
• Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.

Related Conditions & MeSH terms

• Lymphatic Metastasis
• Neoplasm Metastasis
• Neoplasms
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• PSMA-PET
Prostate specific membrane antigen positron emission tomography
• PSMA-PET/MRI
Prostate specific membrane antigen positron emission tomography combined with magnetic resonance imaging
• PSMA-PET/CT
Prostate specific membrane antigen positron emission tomography combined with computed tomography imaging

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	University Hosptial of North Norway	Tromsø
Norway	St Olavs Hospital, Trondheim University Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI	To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI to that of the current standard multiparametric MRI, using histopathology as the gold standard.	1 month
Secondary	Sensitivity and specificity of PSMA PET/MRI	To evaluate the sensitivity and specificity of PSMA PET/MRI to detect positive lymph nodes in high-risk prostate cancer patients in a prospective, multicenter study.	1 month
Secondary	Performance of PSMA PET/MRI versus PET/CT	Compare the performance of PET/MRI to PET/CT for detection of lymph node metastases	1 month