PET/MRI in Patients With Suspected Prostate Cancer

NCT02659527 | Completed Phase 3

• 1 other identifier: The RAPID study
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[rising prostate specific antigen (PSA) after PSA nadir; secondary objective\].

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Superiority of image guided biopsy using multiparametric metabolic hybrid imaging with FEC/PSMA-PET/MRI (Fluorethylcholin/Prostate Specific Membrane Antigen- PET/MRI)

  We hypothesize that the image guided biopsy using multiparametric metabolic hybrid imaging with FEC/PSMA-PET/MRI is superior in the detection of primary localized prostate cancer than the conventional biopsy approach with transrectal ultrasound in patients with suspected prostate cancer (according to the inclusion criteria) and could therefore significantly improve the detection rate of the dominant intraprostatic tumor lesion and reduce the number of biopsies needed for a correct histopathological diagnosis to a minimum in the future (PET/MRI guided biopsy).

  36 months

Secondary Outcomes (2)

• tumor characterization

  5 years

• early biochemical relapse

  5 years

Study Arms (2)

standardized needle biopsy

ACTIVE COMPARATOR

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.

Drug: 68Ga- PSMA-HBED-CC; Device: Biograph mMR, Siemens

image-guided biopsy

EXPERIMENTAL

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.

Drug: 68Ga- PSMA-HBED-CC; Device: Biograph mMR, Siemens

Interventions

68Ga- PSMA-HBED-CC 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.

image-guided biopsy; standardized needle biopsy

Biograph mMR, Siemens 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; standardized needle biopsy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• BSM Diagnostica GmbH Vienna: collaborator
• Siemens Healthcare GmbH: collaborator

Study Sites (1)

Department of Biomedical Imaging and Image-guided Therapy

Vienna, 1090, Austria

Location

Related Publications (3)

• Ning J, Spielvogel CP, Haberl D, Trachtova K, Stoiber S, Rasul S, Bystry V, Wasinger G, Baltzer P, Gurnhofer E, Timelthaler G, Schlederer M, Papp L, Schachner H, Helbich T, Hartenbach M, Grubmuller B, Shariat SF, Hacker M, Haug A, Kenner L. A novel assessment of whole-mount Gleason grading in prostate cancer to identify candidates for radical prostatectomy: a machine learning-based multiomics study. Theranostics. 2024 Aug 1;14(12):4570-4581. doi: 10.7150/thno.96921. eCollection 2024.

  PMID: 39239512 DERIVED

• Papp L, Spielvogel CP, Grubmuller B, Grahovac M, Krajnc D, Ecsedi B, Sareshgi RAM, Mohamad D, Hamboeck M, Rausch I, Mitterhauser M, Wadsak W, Haug AR, Kenner L, Mazal P, Susani M, Hartenbach S, Baltzer P, Helbich TH, Kramer G, Shariat SF, Beyer T, Hartenbach M, Hacker M. Supervised machine learning enables non-invasive lesion characterization in primary prostate cancer with [68Ga]Ga-PSMA-11 PET/MRI. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1795-1805. doi: 10.1007/s00259-020-05140-y. Epub 2020 Dec 19.

  PMID: 33341915 DERIVED

• Aksoy O, Pencik J, Hartenbach M, Moazzami AA, Schlederer M, Balber T, Varady A, Philippe C, Baltzer PA, Mazumder B, Whitchurch JB, Roberts CJ, Haitel A, Herac M, Susani M, Mitterhauser M, Marculescu R, Stangl-Kremser J, Hassler MR, Kramer G, Shariat SF, Turner SD, Tichy B, Oppelt J, Pospisilova S, Hartenbach S, Tangermann S, Egger G, Neubauer HA, Moriggl R, Culig Z, Greiner G, Hoermann G, Hacker M, Heery DM, Merkel O, Kenner L. Thyroid and androgen receptor signaling are antagonized by mu-Crystallin in prostate cancer. Int J Cancer. 2021 Feb 1;148(3):731-747. doi: 10.1002/ijc.33332. Epub 2020 Oct 31.

  PMID: 33034050 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr.med

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

AU (1)