Prostate Cancer RecurrentPET-MR-PSANCT02562131
PET-MR-PSA Prostate Cancer Recidive Study
An observational study of Prostate Cancer Recurrent, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The aim in 2 years is 80 prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy.
Who may be able to join
- the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA > 0.2 ng/ml following radical prostatectomy or PSA > 2.0 ng/ml above the nadir following definitive radiotherapy)
- potential candidates for salvage treatment based on age and co-morbidity.
Who cannot join
- general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
- impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment
Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.
Read the detailed description
The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.
- Conditions
- Prostate Cancer Recurrent
- Keywords
- PET-MR, recidive, PET/MR imaging, 18F-Fluciclovine, radical treatment, recurrence
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.
Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Tone F Bathen, PhD, Principal investigator, The Norwegian University of Science and Technology (NTNU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562131
- Sponsor's protocol ID
- 2015/163-4
- Acronym
- PET-MR-PSA
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2015
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment
- ClinicalTrials.gov ID
- NCT02562131
- Acronym / sponsor ID
- PET-MR-PSA / 2015/163-4
- Conditions
- Prostate Cancer Recurrent
- Keywords
- PET-MR, recidive, PET/MR imaging, 18F-Fluciclovine, radical treatment, recurrence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Sep 2015 (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.
Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.
Detailed description
The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The aim in 2 years is 80 prostate cancer patients with biochemical relapse following radical treatment, or patients with persistently elevated PSA levels after radical prostatectomy.
Key inclusion criteria (2 listed)
- the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA > 0.2 ng/ml following radical prostatectomy or PSA > 2.0 ng/ml above the nadir following definitive radiotherapy)
- potential candidates for salvage treatment based on age and co-morbidity.
Key exclusion criteria (2 listed)
- general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia)
- impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI.
Time frame: 10 years
Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Prostate Cancer Recurrent
RecruitingPhase 2
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer, Adenocarcinoma of the Prostate
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Active, not recruitingPhase 2
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
Prostate
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.
Tone F Bathen, PhD principal investigator
The Norwegian University of Science and Technology (NTNU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Recurrent, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. 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 Norway. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.