PET/MRI in Patients With Suspected Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This diagnostic clinical trial will be conducted according to a randomized, prospective, controlled, double-arm, single-centre design. The control will be implemented by comparing the PET/MRI results with the histopathological finding after radical prostatectomy (positive state), the assumed absence of a relevant prostate cancer focus if PET/MRI guided biopsy and standard biopsy are negative (negative state) and/or the detection of a biochemical tumor relapse \[rising prostate specific antigen (PSA) after PSA nadir; secondary objective\].

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PSMA PET Scan and mpMRI for Prostate Cancer Detection

NCT05820724

Prostate Cancer Diagnosis

NOT_YET_RECRUITING PHASE2

NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway

NCT06672926

Prostate Cancer MRI

NOT_YET_RECRUITING

Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation

NCT06565247

Prostate Cancer

RECRUITING PHASE3

rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

NCT05852041

Prostate Adenocarcinoma Stage I Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 +1 more

RECRUITING EARLY_PHASE1

Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients

NCT02611882

Prostate Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In the last years magnetic resonance imaging (MRI) as well as positron emission tomography (PET) of the prostate have emerged as promising imaging tools. MRI provides mainly morphologic information and, to an increasing degree, functional information on the tumor microenvironment by using multiparametric approaches leading to an increase in diagnostic accuracy. Transition and periurethral zone cancers and the identification of patients' individual risk (e.g. for the development of a metastatic disease after primary treatment) is still a limitation of this method. PET, concerning radiolabelled choline, provides functional and predicting data on tumor metabolism and aggressiveness and has been found to be of complimentary value to morphologic imaging but still with the caveat of false positive and false negative findings. To overcome these limitations of morphological and functional imaging techniques, hybrid imaging systems have been developed and introduced into clinical routine. Additionally, the recently developed 68Ga-labeled Prostate Specific Membrane Antigen (PSMA) provides a highly specific information on a possible metastatic spread of prostate cancer. Thus the combined use of PET-MRI has wide spread applications in prostate cancer diagnosis, staging and treatment planning.

The potentials of this novel technique in general and its impact on assessing patients' individual risk to support a therapy or active surveillance decision in a future modified urological patient management were not yet explored in detail, but an initial prospective clinical trial in 38 patients with a sequential PET/MRI technique demonstrated the ability of a significant improvement of the individual methods. This registered prospective, randomized clinical trial is intended to proof, in a first step, the superiority of PET/MRI vs. the actual clinical standard procedures by applying a stable multiparametric metabolic hybrid imaging protocol. The aim of this study is to reduce the number of unnecessary invasive procedures to a minimum (image guided biopsy) and to enable superior image guided risk stratification.

In this prospective, randomized, multi-arm, multi-treatment clinical trial 220 subjects will be included at 1 site within 3 years. With a maximum follow-up for an early biochemical relapse of 2 years the planned duration should not exceed 5 years. The primary objective will be answered after 36 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standardized needle biopsy

All enrolled patients are examined by means of dual tracer PET / MRI. Images will be interpreted by 4 designated readers. The readers are blinded of the respective results among each other. A consensus of the two principal readers of nuclear medicine and radiology will serve as reference for the guided needle biopsy. Additionally the readers are blinded to any result of the pathological workout until the recruitment of the last patient is finished.

According to the randomization, the standardized 12 core TRUS (TransRectal UltraSound)-guided biopsy is performed without knowledge of imaging findings by the urologist. If the biopsy is negative patients will have an additional image-guided biopsy with 4 more cores samples. After a positive biopsy the subjects be treated according to normal clinical practice.

Group Type ACTIVE_COMPARATOR

68Ga- PSMA-HBED-CC

Intervention Type DRUG

Patients will receive a dual-tracer PET/MRI scan. FEC and 68Ga-PSMA-HBED-CC, for tissue metabolism and surface marker expressions, as specific PET-tracers as well as multiparametric MRI methods (T2w, DCE, DWI) are used.

Biograph mMR, Siemens

Intervention Type DEVICE

All PET-MRI examinations will be performed using a hybrid PET-MRI system (Biograph mMR, Siemens, Germany) capable of simultaneous data acquisition. The system consists of an MRI-compatible state-of the art PET detector integrated in a 3.0-T whole-body MRI scanner.

image-guided biopsy

All enrolled patients are examined by means of dual tracer PET / MRI. Images will be interpreted by 4 designated readers. The readers are blinded of the respective results among each other. A consensus of the two principal readers of nuclear medicine and radiology will serve as reference for the guided needle biopsy. Additionally the readers are blinded to any result of the pathological workout until the recruitment of the last patient is finished.

Patients will have a standardized 12 core TRUS-guided biopsy without knowledge of imaging findings by the urologist. Patients randomized in this arm will have an additional image-guided biopsy with 4 more cores samples. After a positive biopsy the subjects be treated according to normal clinical practice.

Group Type EXPERIMENTAL

68Ga- PSMA-HBED-CC

Intervention Type DRUG

Patients will receive a dual-tracer PET/MRI scan. FEC and 68Ga-PSMA-HBED-CC, for tissue metabolism and surface marker expressions, as specific PET-tracers as well as multiparametric MRI methods (T2w, DCE, DWI) are used.

Biograph mMR, Siemens

Intervention Type DEVICE

All PET-MRI examinations will be performed using a hybrid PET-MRI system (Biograph mMR, Siemens, Germany) capable of simultaneous data acquisition. The system consists of an MRI-compatible state-of the art PET detector integrated in a 3.0-T whole-body MRI scanner.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga- PSMA-HBED-CC

Patients will receive a dual-tracer PET/MRI scan. FEC and 68Ga-PSMA-HBED-CC, for tissue metabolism and surface marker expressions, as specific PET-tracers as well as multiparametric MRI methods (T2w, DCE, DWI) are used.

Intervention Type DRUG

Biograph mMR, Siemens

All PET-MRI examinations will be performed using a hybrid PET-MRI system (Biograph mMR, Siemens, Germany) capable of simultaneous data acquisition. The system consists of an MRI-compatible state-of the art PET detector integrated in a 3.0-T whole-body MRI scanner.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* blood PSA level \> 4.0 ng/ml and
* free-to-total PSA ratio \<22% and/or
* progressive rise of PSA levels in two consecutive blood samples despite antibiotics

Exclusion Criteria

* antiandrogen therapy
* prostate needle biopsy \<21 days before PET/MRI
* known active secondary cancer
* endorectal coil not applicable (e.g. anus praetor with short rectal stump)
* known active prostatitis (e.g. painful DRE)
* known anaphylaxis against gadolinium-DOTA
* patient's written informed consent not given
* needle biopsy and/or prostatectomy compound not available for histology/immunohistochemistry

Eligible Sex

MALE

Accepts Healthy Volunteers

No