Prostatic NeoplasmsNCT02076503
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
A study testing PET-MR 18f-FACBC and histology (gold standard) in people with Prostatic Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- PET-MR 18f-FACBC and histology (gold standard)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to May 2015
- Phase
- Interventional
- 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
- High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer)
- Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection)
Who cannot join
- Previous treatment (for example TURP or hormone therapy)
- Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients.
The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.
- Conditions
- Prostatic Neoplasms
- Being tested
- PET-MR 18f-FACBC, histology (gold standard)
- Keywords
- Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MR 18f-FACBCProcedure or surgery
histology (gold standard)Procedure or surgery
histopathological classification of co-located dissected lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| PET-MR 18F-FACBC | Experimental | Not described Receives: Procedure: PET-MR 18f-FACBC; Procedure: histology (gold standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Anders Angelsen, prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076503
- Sponsor's protocol ID
- 2013/1513
- Status last verified
- Jan 2018
- First submitted
- 10 Feb 2014
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elschot M, Selnaes KM, Sandsmark E, Kruger-Stokke B, Storkersen O, Tessem MB, Moestue SA, Bertilsson H, Bathen TF. A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):695-703. doi: 10.1007/s00259-016-3562-7. Epub 2016 Nov 5.
PubMed 27817158Selnaes KM, Kruger-Stokke B, Elschot M, Willoch F, Storkersen O, Sandsmark E, Moestue SA, Tessem MB, Halvorsen D, Kjobli E, Angelsen A, Langorgen S, Bertilsson H, Bathen TF. 18F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prostate cancer patients. Eur Radiol. 2018 Aug;28(8):3151-3159. doi: 10.1007/s00330-017-5213-1. Epub 2018 Jan 2.
PubMed 29294158
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
- ClinicalTrials.gov ID
- NCT02076503
- Acronym / sponsor ID
- 2013/1513
- Conditions
- Prostatic Neoplasms
- Keywords
- Neoplasm Staging, Positron-Emission Tomography, Magnetic Resonance Imaging, 1-amino-3-fluorocyclobutane-1-carboxylic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Norwegian Cancer Society
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Mar 2014 (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.
Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients.
The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-MR 18F-FACBC | Experimental | Procedure: PET-MR 18f-FACBC, Procedure: histology (gold standard) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- High-risk prostate cancer according to EAU guidelines (Gleason score ≥8 and/or PSA ≥20 ng/ml and/or ≥ cT3a cancer)
- Eligibility for the surgical procedure (radical prostatectomy and bilateral pelvic lymph node resection)
Key exclusion criteria (2 listed)
- Previous treatment (for example TURP or hormone therapy)
- Contraindication for the PET/MR examination (including, but not limited to: pacemaker, aneurysm clips, reduced renal function, metal implants, claustrophobia)
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 |
|---|---|---|
| PET-MR 18f-FACBC | Procedure or surgery | PET-MR 18F-FACBC |
| histology (gold standard)histopathological classification of co-located dissected lymph nodes | Procedure or surgery | PET-MR 18F-FACBC |
Primary outcome
Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases
Time frame: 7 days
Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases
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 5 Jan 2018.
- Results publication: PubMed 27817158Elschot M, Selnaes KM, Sandsmark E, Kruger-Stokke B, Storkersen O, Tessem MB, Moestue SA, Bertilsson H, Bathen TF. A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):695-703. doi: 10.1007/s00259-016-3562-7. Epub 2016 Nov 5.
- Results publication: PubMed 29294158Selnaes KM, Kruger-Stokke B, Elschot M, Willoch F, Storkersen O, Sandsmark E, Moestue SA, Tessem MB, Halvorsen D, Kjobli E, Angelsen A, Langorgen S, Bertilsson H, Bathen TF. 18F-Fluciclovine PET/MRI for preoperative lymph node staging in high-risk prostate cancer patients. Eur Radiol. 2018 Aug;28(8):3151-3159. doi: 10.1007/s00330-017-5213-1. Epub 2018 Jan 2.
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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.
Anders Angelsen, prof study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MR 18f-FACBC and histology (gold standard) in people with Prostatic Neoplasms, run by St. Olavs Hospital 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: finished, as of the sponsor's last update on 5 Jan 2018. 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?
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?
Positive and negative predictive value of 18FACBC PET/MR for detection of lymph node metastases (time frame: 7 days). 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 NCT02076503, which also lists 2 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 5 Jan 2018.