Prostate CancerGUIDE PSMA PETNCT07258056
GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
A study testing PSMA-guided and systematic biopsies in people with Prostate Cancer, run by Mads Ryo Jochumsen at 2 sites in Denmark.
Trial summary
The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd > 0.20. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-guided and systematic biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 3 Nov 2025to Dec 2038
- Phase
- Interventional
- 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
Who may be able to join
- PSAdensity > 0.20
- Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
- MRI within 6 months
- Read and understand danish
- Expected remaining lifetime > 10 years
Who cannot join
- Known prostate cancer
- MRI contraindications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, Aarhus, 8200
Mads R Jochumsen, MD, Ph.D., 78456270, madsjoch@rm.dk
madsjoch@rm.dk
- Recruiting
Goedstrup Hospital
Herning, Herning, 7400
Kasper D Berg, MD, Ph.D., 45 + 78439450, KASPBG@rm.dk
Kasper D Berg, MD, Ph.D.
About this study
Official title: GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)
The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd > 0.20. The main questions it aims to answer are:
Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?
Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.
- Conditions
- Prostate Cancer
- Being tested
- PSMA-guided and systematic biopsies
- Keywords
- PSMA, PET/MRI, Prostate cancer, biopsy guidance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-guided and systematic biopsiesDiagnostic test
Both PSMA-guided and systematic biopsies are performed
| Study group | Role | What they receive |
|---|---|---|
| PSMA-guided and systematic biopsies | Experimental | Both PSMA-guided and systematic biopsies are performed Receives: Diagnostic Test: PSMA-guided and systematic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies
CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2.
The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.
Measured: From enrollment to pathology report is ready, assessed up to 2 years
Secondary outcomes (1)
High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)
A high negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) means that biopsies can safely be avoided in patients with PRIMARY 1-2 lesions only.
Measured: From enrollment to pathology report, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start3 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mads Ryo Jochumsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mads Ryo Jochumsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258056
- Sponsor's protocol ID
- 1-10-72-109-25
- Acronym
- GUIDE PSMA PET
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Relevant data from the study will be made avilable and published, but the investigators do not have permission to share individual participant data with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)
- ClinicalTrials.gov ID
- NCT07258056
- Acronym / sponsor ID
- GUIDE PSMA PET / 1-10-72-109-25
- Conditions
- Prostate Cancer
- Keywords
- PSMA, PET/MRI, Prostate cancer, biopsy guidance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mads Ryo JochumsenUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 2 Dec 2025 (actual)
- 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.
The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd > 0.20. The main questions it aims to answer are:
Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?
Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA-guided and systematic biopsies | Experimental | Diagnostic Test: PSMA-guided and systematic biopsiesBoth PSMA-guided and systematic biopsies are performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PSAdensity > 0.20
- Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
- MRI within 6 months
- Read and understand danish
- Expected remaining lifetime > 10 years
Key exclusion criteria (2 listed)
- Known prostate cancer
- MRI contraindications
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 |
|---|---|---|
| PSMA-guided and systematic biopsiesBoth PSMA-guided and systematic biopsies are performed | Diagnostic test | PSMA-guided and systematic biopsies |
Primary outcome
Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies
Time frame: From enrollment to pathology report is ready, assessed up to 2 years
CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2. The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.
1 secondary outcome
High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)
Time frame: From enrollment to pathology report, assessed up to 2 years
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 Dec 2025.
- Individual participant dataSharing planned: No. Relevant data from the study will be made avilable and published, but the investigators do not have permission to share individual participant data with external researchers.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-guided and systematic biopsies in people with Prostate Cancer, run by Mads Ryo Jochumsen at 2 sites in Denmark.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Contact Mads R Jochumsen, MD, Ph.D. (+45 + 78456270, madsjoch@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies (time frame: From enrollment to pathology report is ready, assessed up to 2 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 Dec 2025.