Prostate CancerPhase 3NCT02659527
PET/MRI in Patients With Suspected Prostate Cancer
A Phase 3 study testing 68Ga- PSMA-HBED-CC and Biograph mMR, Siemens in people with Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga- PSMA-HBED-CC and Biograph mMR, Siemens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2016to Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Biomedical Imaging and Image-guided Therapy
Vienna, 1090
About this study
Official title: Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial
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].
Read the detailed description
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
- Prostate Cancer
- Being tested
- 68Ga- PSMA-HBED-CC, Biograph mMR, Siemens
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga- PSMA-HBED-CCDrug
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, SiemensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 68Ga- PSMA-HBED-CC; Device: Biograph mMR, Siemens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 months
Secondary outcomes (2)
tumor characterization
This method should enable improved tumor characterization. A diagnostic accuracy of >80% is assumed in lesions >5mm (in axial, sagittal and coronal extension) for the ability of the multiparametric metabolic method to differentiate between Gleason ≤3+4=7 (7a) tumors and ≥4+3=7 (7b) tumors (as compared to histological whole mount tumor mapping) and to identify patients with a high risk of developing metastatic disease (as compared to the loss of the transcription factor STAT3(signal transducer and activator of transcription 3) and cell cycle regulator p14 in a molecular pathological workout of the radical prostatectomy specimen).
Measured: 5 years
early biochemical relapse
To evaluate, if the applied parameters of multiparametric metabolic imaging with FEC- and PSMA-PET/MRI are associated with the evidence of an early biochemical relapse after a PSA nadir <0.2ng/ml after primary treatment in a two years follow up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- BSM Diagnostica GmbH Vienna, Siemens Healthcare GmbH
- Responsible party
- Principal investigator, Univ.-Prof. Dr. Marcus Hacker, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659527
- Sponsor's protocol ID
- The RAPID study
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2016
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartenbach M, Rasul S, Grubmuller B, Kramer G, Baltzer P, Helbich T, Eiber M, Hartenbach S, Grahovac M, Susani M, Mazal P, Wadsak W, Einspieler H, Weber M, Kenner L, Haug AR, Hacker M. PSMA-Directed PET/MRI Enables Noninvasive Diagnosis and Prognosis in Patients with Increased PSA Levels: Results from the Prospective Randomized RAPID Trial. J Nucl Med. 2026 Feb 2;67(2):224-231. doi: 10.2967/jnumed.125.270404.
PubMed 41266255Ning 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.
PubMed 39239512Papp 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.
PubMed 33341915Aksoy 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.
PubMed 33034050
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessment of Patients With Clinically Suspected Prostate Cancer After Multiparametric Metabolic Hybrid Imaging to Evaluate Its Potential Clinical Domain: A Prospective, Randomized, Multi-arm, Multi-treatment Clinical Trial
- ClinicalTrials.gov ID
- NCT02659527
- Acronym / sponsor ID
- The RAPID study
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- BSM Diagnostica GmbH Vienna, Siemens Healthcare GmbH
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standardized needle biopsy | Active comparator | Drug: 68Ga- PSMA-HBED-CC, Device: Biograph mMR, SiemensAll 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. |
| image-guided biopsy | Experimental | Drug: 68Ga- PSMA-HBED-CC, Device: Biograph mMR, SiemensAll 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga- PSMA-HBED-CCPatients 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. | Drug | image-guided biopsy, standardized needle biopsy |
| Biograph mMR, SiemensAll 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. | Device | image-guided biopsy, standardized needle biopsy |
Primary outcome
Superiority of image guided biopsy using multiparametric metabolic hybrid imaging with FEC/PSMA-PET/MRI (Fluorethylcholin/Prostate Specific Membrane Antigen- PET/MRI)
Time frame: 36 months
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).
2 secondary outcomes
tumor characterization
Time frame: 5 years
early biochemical relapse
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 41266255Hartenbach M, Rasul S, Grubmuller B, Kramer G, Baltzer P, Helbich T, Eiber M, Hartenbach S, Grahovac M, Susani M, Mazal P, Wadsak W, Einspieler H, Weber M, Kenner L, Haug AR, Hacker M. PSMA-Directed PET/MRI Enables Noninvasive Diagnosis and Prognosis in Patients with Increased PSA Levels: Results from the Prospective Randomized RAPID Trial. J Nucl Med. 2026 Feb 2;67(2):224-231. doi: 10.2967/jnumed.125.270404.
- Derived from this study: PubMed 39239512Ning 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.
- Derived from this study: PubMed 33341915Papp 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.
- Derived from this study: PubMed 33034050Aksoy 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.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga- PSMA-HBED-CC and Biograph mMR, Siemens in people with Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of image guided biopsy using multiparametric metabolic hybrid imaging with FEC/PSMA-PET/MRI (Fluorethylcholin/Prostate Specific Membrane Antigen- PET/MRI) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659527, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.