Novel Imaging in Staging of Primary Prostate Cancer

NCT03537391 | Completed

• 1 other identifier: T95/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer (PC) is the most common cancer among men and one quarter of diagnosed PC are metastatic at the time of diagnosis. Accurate staging is paramount as the stage is the most important factor when treatment decisions are made. The stage is also the single most important prognostic factor. Currently, traditional imaging methods for detection of PC metastasis, including bone scan (BS) and contrast enhanced whole-body computer tomography (CT), are rather inaccurate. Respectively, novel imaging techniques are evolving and novel imaging modalities are emerging in PC diagnostics and staging, but their clinical relevance is unclear and lacking prospective studies comparing traditional imaging with novel imaging. This prospective single-institutional study compares the diagnostic accuracy of novel imaging modalities to traditional imaging modalities aiming to find the most appropriate staging modality in high-risk PC at the time of initial staging.

Conditions

High Risk Prostate Cancer

Keywords

prostate cancer; imaging of prostate cancer; staging of prostate cancer; prostate specific membrane antigen (PSMA); positron emission tomography; bone scintigraphy; whole body magnetic resonance imaging; whole body computer tomography; single photon emission tomography (SPECT)

Outcome Measures

Primary Outcomes (1)

• To compare the diagnostic accuracy of 18F-PSMA-1007-PET/CT (PSMA-PET/CT) to 99mTc-HMDP planar bone scintigraphy (planar BS) in pessimistic, patient-based analysis detecting of bone metastases in the initial staging of high-risk PC patients.

  Comparison of area under curve (AUC) values in receiver operating characteristic (ROC) curve of PSMA-PET/CT to planar BS in pessimistic, patient-based analysis detecting of bone metastases. The power calculations are made on the basis of previously published work, the SKELETA trial. To be able to detect the 0,19 difference (in AUC values) using a two-tailed test with a power of 80% at a significance level of 0.05 in a 2:1 ratio of sample sizes in negative/positive groups, 48 negative cases and 24 positive cases are required. Equivocal findings of the imaging modalities will be classified either as suggestive for metastases (pessimistic analysis) or suggestive for non-metastatic origin (optimistic analysis). AUC values will be calculated using the trapezoid rule and compared using a method described by Hanley and McNeil, two-sided p-values will be calculated.

  1 year

Secondary Outcomes (5)

• Sensitivity of each imaging modality will be measured in initial staging of nodal, soft tissue and bone metastasis

  1 year

• Specificity of each imaging modality will be measured in initial staging of nodal, soft tissue and bone metastasis

  1 year

• Diagnostic accuracy each imaging modality will be measured in initial staging of nodal, soft tissue and bone metastasis

  1 year

• The effect of staging on clinical treatment-decisions

  1 year

• AUC values from receiver operating characteristic curve of each imaging modality will be measured in initial staging of nodal, soft tissue and bone metastasis

  1 year

Study Arms (1)

Imaging based staging of high risk PC

EXPERIMENTAL

Each individual study patient will be imaged for PC metastasis detection with each different imaging modalities as follows: Traditional imaging (clinical standard imaging); 1. Whole-body contrast enhanced computer tomography 2. Planar bone scintigraphy Novel imaging (investigational imaging); 3. SPECT/CT (investigational imaging) 4. 18F-PSMA-PET/CT (investigational imaging) 5. Whole-body MRI (investigational imaging) In order to define the true nature of the findings from each different imaging modality, comparison with best valuable comparator (BvC) is made. Consensus reading of all imaging modalities and follow-up data of clinical, imaging, histopathological and laboratory results are used to define BvC.

Diagnostic Test: Whole body contrast enhanced computer tomography; Diagnostic Test: 99mTC-HMDP planar bone scintigraphy (BS); Diagnostic Test: 99mTc-HMDP single photon emission computer tomography/computer tomography; Diagnostic Test: Whole-body magnetic resonance imaging; Diagnostic Test: Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography

Interventions

Whole body contrast enhanced computer tomography DIAGNOSTIC_TEST

Computed tomography of the thorax, abdomen and pelvis will be performed as a part of routine clinical evaluation protocol. The imaging will be done with contrast agent if there are no clinical contraindications for the use of contrast agent.

Also known as: wbCE-CT

Imaging based staging of high risk PC

99mTC-HMDP planar bone scintigraphy (BS) DIAGNOSTIC_TEST

Planar bone scintigraphy will be performed as a part of routine clinical evaluation protocol. The subjects will be positioned supine on a Discovery NM/CT 670 CZT, a digital SPECT/CT scanner (General Electric Healthcare). The scanner includes a dual-detector, free-geometry integrated nuclear imaging camera with the advanced digital CZT detector technology combined with the high-performance Optima CT540 subsystem. Whole-body planar images will be scanned from the anterior and posterior views three hours after the intravenous injection of 670 MBq of 99mTc-HMDP. A wide-energy high-resolution (WEHR) collimator, a scan speed of 13 cm/min, a zoom of 1.0 and a matrix size of 256 x 1024 are used in the scintigraphy.

Also known as: Planar BS

Imaging based staging of high risk PC

99mTc-HMDP single photon emission computer tomography/computer tomography DIAGNOSTIC_TEST

SPECT/CT imaging will be carried out after acquisition of the planar images with the same scanner. Three bed positions of SPECT data will be acquired from the top of the head to mid femoral level using WEHR collimators. A non-circular orbit, 60 views with 15-s scanning time per view will be acquired during 180 degrees of rotation. A 128 x 128 matrix size, a zoom of 1.0 and 15% photopeak and lower scatter energy windows are used. After SPECT a CT topogram and a low-dose tomogram with a modulated mAs (noise index \~ 70), 120 kVp, a pitch of 1.35 and a 2.5-mm slice thickness are scanned. The co-registration of SPECT and CT data is verified after which the SPECT images are reconstructed using modern iterative ordered subsets expectation (OSEM) reconstruction algorithm from General Electric or Hermes Medical Solutions, which includes, e.g., 10 iterations and 5 subsets and attenuation, collimator and scatter corrections.

Also known as: SPECT/CT

Imaging based staging of high risk PC

Whole-body magnetic resonance imaging DIAGNOSTIC_TEST

Magnetic resonance imaging examination will be performed using a 1.5T (Philips 1.5T Ingenia, Best, Netherlands and/or Siemens 1.5T Aera/Avant, Erlangen, Germany) or 3T (Philips 3T Ingenia, Best, Netherlands and/or Siemens 3T Skyra fit, Erlangen, German) MR system. The body matrix coil in combination with a spinal coil will be used for image acquisition. T1-weighted anatomic imaging, STIR fat suppressed images and DWI will be performed in axial and coronal directions. DWI will be obtained with single-shot 2D spin-echo echo-planar imaging. The total scan time will be approximately 50 minutes.

Also known as: wbMRI

Imaging based staging of high risk PC

Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography DIAGNOSTIC_TEST

18F-PSMA-1007 is produced by radiolabelling with fluorine-18 produced by irradiating oxygen-18. Administration of the formulated solution is done shortly (\<10h) after production. Imaging is carried out with digital PET/CT scanner (Discovery MI;General Electric Medical Systems, Milwaukee, WI, USA). The patients receive intravenous injection of 200-300 MBq (3 MB/kg) of 18F-PSMA-1007 diluted in 3-5 ml of saline as a 60-sec bolus which will be promptly flushed with saline. Before data acquisition patients will be asked to void. A static emission scan will be acquired 60-min from tracer injection over whole body. The sinogram data will be corrected for deadtime, decay and photon attenuation and reconstructed in a 256x256 matrix. Image reconstruction follows a fully 3D maximum likelihood ordered subsets expectation maximization algorithm incorporating random and scatter correction with two iterations and 28 subsets.The final in-plane full-width half-maximum of the systems is \< 6 mm.

Also known as: 18F-PSMA-1007-PET/CT

Imaging based staging of high risk PC

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed PC without previous PC treatment
• High-risk PC defined with one or more of the following criteria: Gleason ≥4+3, PSA ≥20, cT≥3a
• Adequate physical status defined (by treating clinician) as capability to undergo some form of active treatment for the PC and the physical status allowing the patient to undergo all study imaging modalities
• Signed informed consent

You may not qualify if:

• Previous PC treatment. Short-term androgen deprivation therapy is permitted if necessary for symptomatic and/or very high-risk PC patients
• Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
• Claustrophobia

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

Department of Urology

Turku, 20521, Finland

Location

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Peter Boström, M.D.Ph.D

  Department of urology, Turku University Hospital, VSSHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Imaging modalities will be read blindly without the knowledge of results of the other imaging modalities. Readers will only know that a patient has prostate cancer with high risk for metastases. All imaging data will be analyzed visually with classifying lesions as normal, equivocal or metastatic.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a prospective single-institutional study comparing the diagnostic accuracy of novel imaging modalities to traditional imaging modalities among high risk prostate cancer patients at initial diagnosis

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 25, 2018
• Study Start: March 1, 2018
• Primary Completion: September 22, 2019
• Study Completion: May 2, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

FI (1)