COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) (COMBINE-P)

COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) - A Multicentre Retrospective Analysis in the European Prostate Cancer Centres of Excellence for Prostate Cancer (EPCCE)

This retrospective, multicentre comparative analysis aims to evaluate a new staging method for i) improved detection of intraprostatic index lesions, ii) local T-staging and iii) lymph node (LN) staging in men with clinically significant prostate cancer (csPCa) at intermediate/high risk by combining prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging using different tracers ((18)F) DCFPyL, Gallium-68, Fluor-18) and multiparametric magnetic resonance imaging (MRI) in patients with prostate cancer (PCa) who subsequently underwent radical prostatectomy (RP). Another secondary endpoint will be the additional value of PSMA-PET/CT in men with unremarkable MRI. Men at intermediate risk (PSA > 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA > 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI followed by RP will be analysed in three different subgroups corresponding to the modalities i) PSMA-PET/CT with 18-F-DCFPyL (subgroup/arm A), ii) Gallium-68 PSMA-PET/CT (subgroup/arm B) and Fluorine-18 PSMA-PET/CT (subgroup/arm C).

The validation of the accuracy of the detection of intraprostatic index lesions, local and lymph node staging by MRI and PSMA-PET-CT with different tracers is carried out using the histological radical prostatectomy specimens.

In addition, the prediction of the International Society of Urolgenital Pathology (ISUP) graduation group (GG) within intraprostatic index lesions will be determined using the SUV (standardised uptake value) in PSMA-PET-CT and using ADC values (Apparent Diffusion Coefficient of the diffusion-weighted MRI sequence) in MRI (7,8). The ability of PSMA-PET-CT to predict extraprostatic, i.e. capsule-transcending, tumour growth is also analysed in comparison with MRI. In addition, the correlation of tumour localisation (right vs. left) in relation to positive lymph nodes (right vs. left) is analysed. Finally, the added value of PSMAPET-CT in the case of negative, unsuspicious MRI is determined.

Overall, our analysis aims to improve patient care by analysing the potential of non-invasive "digital biopsy" in terms of lesion detection and prediction of the histological grading group.

In addition, a proof-of-concept for personalised lymph node dissection based on prediction of lymph node metastasis and patient-tailored nerve sparing with accurate prediction of extracapsular extension will be tested based on combined preoperative PSMA-PET and MRI imaging. The results of these two analyses will have a direct impact on clinical practice and the further use of highly specialised imaging.

In addition, this multi-centre data analysis will provide the European Prostate Cancer Center of Excellence (EPCCE) group with a proof-of-concept for future projects.

Study Overview

• Status: Active, not recruiting
• Conditions: High-risk Prostate Cancer; Intermediate-risk Prostate Cancer
• Intervention / Treatment: Diagnostic test: PSMA-11

Detailed Description

Study protocol - COMBINE-P

1. Please enter a meaningful study title that describes the project at hand

   COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) - A multicentre retrospective analysis in the European Prostate Cancer Centres of Excellence for Prostate Cancer (EPCCE)

2. Name and title of the study coordinators, degree/ profession, institute/ clinic

Prof. Dr Jan Philipp Radtke, Deputy Director and Senior Consultant, Department of Urology, Düsseldorf University Hospital Prof. Dr Peter Albers, Clinic Director, Clinic for Urology, Düsseldorf University Hospital Dr Isabelle Busshoff, Assistant Physician, Department of Urology, Düsseldorf University Hospital

2.1 Study Site Coordinators, degree/ profession, institute/ clinic 2.1.1 Germany - University Hospital Munich - Ludwigs-Maximilian-University Munich Prof. Dr Christian Stief, Full Professor of Urology and Chairman, Department of Urology Dr Thilo Westhofen, Consultant, Department of Urology 2.1.2 Germany - University Hospital Tübingen Prof. Dr Arnulf Stenzl, Professor of Urology and Chairman, Department of Urology Prof. Dr Steffen Rausch, Professor of Urology, Department of Urology, University Hospital Tübingen 2.1.3 Germany - University Hospital Bochum Prof. Dr Joachim Nodus, Full Professor of Urology, Marien Hospital Herne University of Ruhr-University Bochum Prof. Dr Florian Roghmann, Professor of Urology, Marien Hospital Herne University of Ruhr-University Bochum 2.1.4 Germany - University Hospital Düsseldorf Prof. Dr Lars Schimmöller, Institute of Diagnostic and Interventional Radiology Prof. Dr Frederik L. Giesel, Department of Nuclear Medicine 2.1.5 United Kingdom - Christie Clinic Foundation Trust Manchaster Prof. Dr Vijay Sangar, Full Professor of Urology, Department of Urology 2.1.6 Belgium - University Hospital Leuven Prof. Dr Steven Joniau, Full Professor of Urology, Department of Urology Prof. Dr Karolien Goffin, Full Professor of Nuclear Medicine , Department of Nuclear Medicine 2.1.7 France - Hospital Civils de Lyon Prof. Dr Alain Ruffion, Full Professor of Urology, Department of Urology 2.1.8 Switzerland - University Hospital Bern Prof. Dr George Thalmann, Professor of Urology, Department of Urology 2.1.9 Italy - Hospital IRCCS San Raffaele Milan Prof. Dr Francesco Montorsi, Full Professor of Urology, Department of Urology Prof. Dr Alberto Briganti, Professor of Urology, Department of Urology Dr Armando Stabile, Consultant, Department of Urology 2.1.10 Austria - University Hospital Vienna Prof. Dr Shahrokh Shariat, Full Professor of Urology, Department of Urology Dr Pawel Rajwa, Consultant, Department of Urology 2.1.11 Sweden - Lund University, Skane University Hospital Prof. Dr Anders Bjartell, Professor of Urology, Department of Urology

3.

a. Is this an initial application or is there already an ethics vote from another EC? First vote

4. Please provide a brief summary of your study. Please explain the aim of the study and what new findings you are expecting

This retrospective, multicentre comparative analysis aims to evaluate a new staging method for i) improved detection of intraprostatic index lesions, ii) local T-staging and iii) lymph node (LN) staging in men with clinically significant prostate cancer (csPCa) at intermediate/high risk by combining prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging using different tracers ((18)F) DCFPyL, Gallium-68, Fluor-18) and multiparametric magnetic resonance imaging (MRI) in patients with prostate cancer (PCa) who subsequently underwent radical prostatectomy (RP). Another secondary endpoint will be the additional value of PSMA-PET/CT in men with unremarkable MRI. Men at intermediate risk (PSA > 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA > 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI followed by RP will be analysed in three different subgroups corresponding to the modalities i) PSMA-PET/CT with 18-F-DCFPyL (subgroup/arm A), ii) Gallium-68 PSMA-PET/CT (subgroup/arm B) and Fluorine-18 PSMA-PET/CT (subgroup/arm C) (1-6). The validation of the accuracy of the detection of intraprostatic index lesions, local and lymph node staging by MRI and PSMA-PET-CT with different tracers is carried out using the histological radical prostatectomy specimens. In addition, the prediction of the International Society of Urolgenital Pathology (ISUP) graduation group (GG) within intraprostatic index lesions will be determined using the SUV (standardised uptake value) in PSMA-PET-CT and using ADC values (Apparent Diffusion Coefficient of the diffusion-weighted MRI sequence) in MRI (7,8). The ability of PSMA-PET-CT to predict extraprostatic, i.e. capsule-transcending, tumour growth is also analysed in comparison with MRI. In addition, the correlation of tumour localisation (right vs. left) in relation to positive lymph nodes (right vs. left) is analysed. Finally, the added value of PSMAPET- CT in the case of negative, unsuspicious MRI is determined.

Overall, our analysis aims to improve patient care by analysing the potential of non-invasive "digital biopsy" in terms of lesion detection and prediction of the histological grading group.

In addition, a proof-of-concept for personalised lymph node dissection based on prediction of lymph node metastasis and patient-tailored nerve sparing with accurate prediction of extracapsular extension will be tested based on combined preoperative PSMA-PET and MRI imaging. The results of these two analyses will have a direct impact on clinical practice and the further use of highly specialised imaging. In addition, this multi-centre data analysis will provide the European Prostate Cancer Center of Excellence (EPCCE) group with a proof-of-concept for future projects.

5. Please indicate which of the provisions and principles in the applicable version are relevant to the project and will therefore be taken into account and observed during implementation.

a. Professional code of conduct for doctors b. Declaration of Helsinki c. GDPR d. Federal Data Protection Act e. NRW State Data Protection Act f. Health Data Protection Act NRW

6. Please state the exact period to which the planned data collection relates (e.g. "01/2005 - 12/2014" or "01/2007 to the date of application").

Multicentre, retrospective data analysis. At the University Hospital Düsseldorf of the Heinrich-Heine University Düsseldorf, the retrospective data analysis will cover the period 04/2021-04/2023. At the other centres, the retrospective data analysis will cover the period 01/2016-04/2023.

7. Case number planning Please enter the planned number of cases (e.g. n = x patients).

Multicentre n = 600 patients. At the University Hospital Düsseldorf approx. n=60 patients.

8. Informed consent

1. Was written consent obtained from the patient? No
2. If "No" In addition to the time and cost involved in following up the treated patients to obtain their "informed consent", the probability of non-consent can be considered lowoverall. The retrospective analysis of the data as part of the research project is based exclusively on data acquired in the course of medically necessary treatment at the Department of Urology. A retrospective collection of additional data is not planned. The data used is extracted from archived data of the Clinic for Urology by employees of the Clinic for Urology who are bound to confidentiality, with immediate anonymisation, so that it is not possible to trace the data back to the individual patient.

The use of the data has no further effect on the treatment of patients. The evaluation does not result in any health or ongoing care risk for the patient. The analysis does not result in any relevant therapy outcomes for the patient. The patients analysed in the retrospective analysis have already consented to the use of their collected data for scientific purposes as part of the MRProRoutine study (study number: 5910R; study registration ID: 201/0341/1).

c. Are there any indications that patients (including individual patients) have objected to their data being used for research purposes? There is no evidence for this exception.

9. Data management

1. What is the source of the data? Data is collected from archived patient files of patients from the Department of Urology at the University Hospital Düsseldorf. As part of the multicentre, retrospective data analysis, the anonymised data of the HHU patients are compared with those of the Inselspital Bern, the University Hospital Vienna, the Hospital IRCCS San Raffaele Milan, Anser/ERASMUS University Hospital Rotterdam, the Hospital Civils Lyon, University Hospital Leuven/Belgium, University Hospital Lund/Sweden, University Hospital Tübingen, University Hospital Ludwigs- Maximilian University Munich, from the Medico patient information system are stored in a database. In addition, data from the PACS image processing and information systems of the University Hospital Düsseldorf, the Inselspital Bern, the University Hospital Vienna, the Hospital IRCCS San Raffaele Milan, Anser/ERASMUS University Hospital Rotterdam, the Hospital Civils Lyon, the University Hospital Leuven, the University Hospital Lund/Sweden, the University Hospital Tübingen, the Hospital Herne of the University Hospital of the Ludwig Maximilian University Munich are stored retrospectively and anonymised.
2. For data from patient files: Were the patients treated in your clinic? Yes.
3. How is the data collected? Anonymised at source.
4. How is the data coded? By means of an ascending series of numbers.
5. Who collects the data? Dr Isabelle Bußhoff, Assistant Physician (Clinic for Urology, UKD) Prof Dr Jan Philipp Radtke (Clinic for Urology, UKD) Prof Roghmann Florian (Department of Urology, Marien Hospital Herne) Prof Dr Georg Thalmann (Department of Urology, Inselspital Bern) Prof Dr Shahrokh Shariat (Department of Urology, University Hospital Vienna) Prof Dr Francesco Montorsi (Department of Urology, Hospital IRCCS San Raggaele Milan) Prof Florian Roghmann (Clinic for Urology, Marien Hospital Herne) Prof Dr Chris Bangma (Anser/ERASMUS University Medical Center Rotterdam) Prof Dr Alain Ruffion (Clinic for Urology, Hospital Civils Lyon) Prof Dr Steven Joniau (Department of Urology, University Hospital Leuven) Prof Dr Karolien Goffien (Department of Nuclear Medicine, University Hospital Leuven) Prof Dr Christian Stief (Department of Urology, University Hospital of the Ludwig Maximilian University of Munich) Prof Dr Steffen Rausch (Department of Urology, University Hospital Tübingen) Prof Andrers Bjartell (Department of Urology, Lund University Hospital)
6. Who anonymises the data? Dr Isabelle Bußhoff, assistant doctor (Clinic for Urology) Prof Dr Georg Thalmann (Department of Urology, Inselspital Bern) Prof Dr Shahrokh Shariat (Department of Urology, University Hospital Vienna) Prof Roghmann Florian (Department of Urology, Marien Hospital Herne) Prof Dr Francesco Montorsi (Department of Urology, Hospital IRCCS San Raggaele Milan) Prof Dr Chris Bangma (Anser/ERASMUS University Medical Center Rotterdam) Prof Dr Alain Ruffion (Clinic for Urology, Hospital Civils Lyon) Prof Dr Steven Joniau (Department of Urology, University Hospital Leuven) Prof Dr Karolien Goffien (Department of Nuclear Medicine, University Hospital Leuven) Prof Dr Christian Stief (Department of Urology, University Hospital Ludwigs- Maximilian University Munich) Prof Dr Steffen Rausch (Department of Urology, University Hospital Tübingen) Prof Andrers Bjartell (Department of Urology, Lund University Hospital)
7. Who analyses the data? Dr Isabelle, Bußhoff, Assistant Physician (Clinic for Urology) Prof Dr Jan Philipp Radtke Prof Dr Frederik L. Giesel Prof Dr Lars Schimmöller
8. Who has access to the assignment key? There is no allocation key as the data is anonymised
9. Where is the allocation key kept? There is no allocation key as the data is anonymised
10. How is the assignment key saved? There is no allocation key as the data is anonymised
11. Where is the research data stored? Please note that the allocation key must not be kept/saved in the same folder/directory as the pseudonymised research data. The data is stored in a password-protected Excel database on the server system of the University Hospital Düsseldorf.

The data from all centres is stored in the PIONEER data platform via the CASTOR Programme of the European Association of Urology (EAU) (https://prostatepioneer.

eu/big-data-platform/pioneer-data-processing/). In the meantime, the applicants have successfully acquired the data storage in PIONEER and the funding for this from the EAU and the EAU Research Foundation.

The data exchange models and data encryption of the PIONEER platform are described below: PIONEER works with two data access models - a centralised and a federated model. In the centralised data exchange model, a copy of the e-identified data is transferred to PIONEER, converted and stored in a central data warehouse for research purposes.

In the federated model, data owners standardise their own data sets and set up analysis tools within their own data environment and make them available on request.

The centralised model will incorporate data by converting population-based registries and epidemiological research data into a common OMOP (Observational Medical Outcomes Partnership) data model to enable the systematic analysis of different observational databases.

Finally, the PIONEER Big Data Platform will not only provide access to data but also analytical tools (ATLAS, R) in a single innovative data platform that utilises two existing data platforms, tranSMART and OHDSI, developed in previous IMI projects. Within PIONEER, the data will not be personally identifiable, i.e. the data has been deidentified to ensure sufficient anonymity so that the person cannot be identified. As a result of this anonymisation process, the data within PIONEER's Big Data platform is not classified as personal data and as such the use of the data complies with all applicable data protection laws at EU level and does not fall within the scope of the General Data Protection Regulation (GDPR) without compromising the clinical relevance of the data. PIONEER achieves this by using two database models: A federated and a centralised database model. In the federated database model, the data does not leave its original location but is queried remotely, with PIONEER bringing the analysis to the data. This essentially means that the data remains anonymous to the researchers accessing the federated database. Data from a variety of sources are effectively 'linked' temporarily to answer specific queries. Individual data providers retain ownership and control of their data and only allow queries in response to authorised requests. This model has been used successfully by other IMI projects such as EMIF-AD.

In the centralised database model, data is physically moved from the data provider to the centralised PIONEER server. To achieve this, PIONEER uses two anonymisation methods. The first is the complete removal of all direct identifiers (such as patient, name, number, photos or other images that could allow identification). The second is "generalisation", which addresses quasi-identifiers. "Generalisation" replaces the values of a particular attribute with less specific values or dilutes the attributes of affected individuals by modifying the respective scales or magnitudes. If the value is a categorical value, it can be changed to another categorical value that denotes a broader concept of the original categorical value. If the value is numeric, it can be changed to a range of values. For example, the granularity of individual birth rates can be reduced by generalising them to a date range or grouping them by month or year.

Other numeric attributes (e.g. age, salary, weight, height or the dose of a drug) can be generalised by banding.

By using the federated database model and applying the de facto anonymisation process to data entered into the centralised database, PIONEER does not process any personal data and therefore complies with data protection law and does not require any special authorisations, consents or approvals in relation to the project (https://prostate-pioneer.eu/big-data-platform/pioneer-data-processing/).

10. Use of image and sound material

a. Will image or sound material be analysed retrospectively as part of this study? Yes b. If "Yes": How is anonymisation carried out here? The data required for the study from the image material used is extracted directly from the image material from the PACS in anonymised form. The image material is therefore limited to the MRI and PET-CT images. Anonymisation is performed automatically within the respective PACS software used at the centre.

11. Utilisation of genetic information

a. Does the study use genetic information that allows the identification of a person? No b. If "Yes": Have the subjects/patients consented to the use of their genetic data for research purposes? Not applicable.

12. Fees

a. How is the study financed? The fees are financed by the EAU Research Foundation: EAU Research Foundation, Mr E.N. van Kleffensstraat 5, 6842 CV Arnhem, The Netherlands. Data storage in PIONEER is funded by the company Exini: EXINI Diagnostics AB, Scheelevägen 27, 223 70 Lund, Sweden.

13. Other information on the study No further details

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna
• Belgium
  • Leuven, Belgium
    • KU Leuven
• Germany
  • Düsseldorf, Germany, 40225
    • University Hospital Düsseldorf
  • Herne, Germany
    • Marienhospital Herne
  • Munich, Germany
    • Ludwig-Maximilians-University Munich
  • Tübingen, Germany
    • University Hospital Tübingen
• India
  • Kolkata, India
    • Fortis Hospital
• Italy
  • Milan, Italy
    • San Raffaele University Hospital Milan
• Sweden
  • Lund, Sweden
    • Lund University Hospital
• Switzerland
  • Bern, Switzerland
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men at intermediate risk (PSA > 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA > 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI and subsequentially RP will be analyzed in three different subgroups, assigned to the modalities they underwent in staging in addition to MRI: i) PSMA-PET/CT using 18-F-DCFPyL (subgroup/arm A), ii) PSMA-PET/CT using Gallium-68 (subgroup/arm B) and PSMA-PET/CT using Fluorine-18 (subgroup/arm C). Validation of the accuracy of intraprostatic lesion detection, local staging and of LN-Staging by MRI or PSMA-PET/CT with different tracers is confirmed after radical prostatectomy.

Description

Inclusion Criteria:

1. Men aged from 45 to 80 years
2. Men with intermediate risk or high risk csPCa
3. Men who underwent RP
4. Men who underwent multiparametric MRI and PSMA-PET/CT before RP

Exclusion Criteria:

a) Men with known prostate cancer, who did not underwent RP and who did not underwent MRI or PSMA-PET-CT

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients staged with PSMA-PET/CT of several tracers prior to Radical Prostatectomy; Men at intermediate risk (PSA > 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA > 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI followed by RP will be analysed in three different subgroups corresponding to the modalities i) PSMA-PET/CT with 18-F-DCFPyL (subgroup/arm A), ii) Gallium-68 PSMA-PET/CT (subgroup/arm B) and Fluorine-18 PSMA-PET/CT (subgroup/arm C)

Diagnostic test: PSMA-11; PSMA-PET/CT using 68Gallium or 18Fluor or 18DCFPyl as staging prior to Radical Prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome includes the correct LN-staging after radical prostatectomy with the use of PSMA-PET-CT with different tracers and mpMRI in patients with significant prostate cancer (ISUP grade group ≥ 2) of intermediate- or high-risk group	The primary outcome includes the correct LN-staging after radical prostatectomy with the use of PSMA-PET-CT with different tracers and mpMRI in patients with significant prostate cancer (ISUP grade group ≥ 2) of intermediate- or high-risk group	01.01.2026-31.12.2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• ISUP GG prediction by SUV (standardized uptake value) and ADC (apparent diffusion coefficient) values on mpMRI	• ISUP GG prediction by SUV (standardized uptake value) and ADC (apparent diffusion coefficient) values on mpMRI	01.12.2026-31.12.2026
Extraprostatic disease	Extraprostatic disease measured by PSMA-PET/CT and MRI	01.12.2026-31.12.2026
Significant prostate cancer detection by one modality	Significant prostate cancer detected by PSMA-PET/CT or MRI that has not been detected by the other modality	01.12.2026-31.12.2026

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Medical University of Vienna; KU Leuven; Erasmus Medical Center; Ludwig-Maximilians - University of Munich; University of Bern; Lund University Hospital; University Hospital, Paris; Universität Tübingen; San Raffaele University Hospital, Italy; Marienhospital Herne; European Association of Urology Research Foundation; Fortis Hospital, India
• Investigators: Study Chair: Jan Philipp Radtke, Professor Dr. med., Heinrich-Heine University, Duesseldorf; Principal Investigator: Isabelle Busshoff, Dr. med., Heinrich-Heine University, Duesseldorf; Study Director: Peter Albers, Professor Dr. med., Heinrich-Heine University, Duesseldorf

Publications and helpful links

General Publications

• Perera M, Papa N, Christidis D, Wetherell D, Hofman MS, Murphy DG, Bolton D, Lawrentschuk N. Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Dec;70(6):926-937. doi: 10.1016/j.eururo.2016.06.021. Epub 2016 Jun 28.
• Giesel FL, Hadaschik B, Cardinale J, Radtke J, Vinsensia M, Lehnert W, Kesch C, Tolstov Y, Singer S, Grabe N, Duensing S, Schafer M, Neels OC, Mier W, Haberkorn U, Kopka K, Kratochwil C. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):678-688. doi: 10.1007/s00259-016-3573-4. Epub 2016 Nov 26.
• Perera M, Papa N, Roberts M, Williams M, Udovicich C, Vela I, Christidis D, Bolton D, Hofman MS, Lawrentschuk N, Murphy DG. Gallium-68 Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer-Updated Diagnostic Utility, Sensitivity, Specificity, and Distribution of Prostate-specific Membrane Antigen-avid Lesions: A Systematic Review and Meta-analysis. Eur Urol. 2020 Apr;77(4):403-417. doi: 10.1016/j.eururo.2019.01.049. Epub 2019 Feb 14.
• Mazzone E, Cannoletta D, Quarta L, Chen DC, Thomson A, Barletta F, Stabile A, Moon D, Eapen R, Lawrentschuk N, Montorsi F, Siva S, Hofman MS, Chiti A, Murphy DG, Briganti A, Perera ML. A Comprehensive Systematic Review and Meta-analysis of the Role of Prostate-specific Membrane Antigen Positron Emission Tomography for Prostate Cancer Diagnosis and Primary Staging before Definitive Treatment. Eur Urol. 2025 Jun;87(6):654-671. doi: 10.1016/j.eururo.2025.03.003. Epub 2025 Mar 27.
• Koerber SA, Utzinger MT, Kratochwil C, Kesch C, Haefner MF, Katayama S, Mier W, Iagaru AH, Herfarth K, Haberkorn U, Debus J, Giesel FL. 68Ga-PSMA-11 PET/CT in Newly Diagnosed Carcinoma of the Prostate: Correlation of Intraprostatic PSMA Uptake with Several Clinical Parameters. J Nucl Med. 2017 Dec;58(12):1943-1948. doi: 10.2967/jnumed.117.190314. Epub 2017 Jun 15.
• Rowe SP, Campbell SP, Mana-Ay M, Szabo Z, Allaf ME, Pienta KJ, Pomper MG, Ross AE, Gorin MA. Prospective Evaluation of PSMA-Targeted 18F-DCFPyL PET/CT in Men with Biochemical Failure After Radical Prostatectomy for Prostate Cancer. J Nucl Med. 2020 Jan;61(1):58-61. doi: 10.2967/jnumed.119.226514. Epub 2019 Jun 14.
• Afshar-Oromieh A, Babich JW, Kratochwil C, Giesel FL, Eisenhut M, Kopka K, Haberkorn U. The Rise of PSMA Ligands for Diagnosis and Therapy of Prostate Cancer. J Nucl Med. 2016 Oct;57(Suppl 3):79S-89S. doi: 10.2967/jnumed.115.170720.
• Afshar-Oromieh A, Malcher A, Eder M, Eisenhut M, Linhart HG, Hadaschik BA, Holland-Letz T, Giesel FL, Kratochwil C, Haufe S, Haberkorn U, Zechmann CM. PET imaging with a [68Ga]gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of tumour lesions. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):486-95. doi: 10.1007/s00259-012-2298-2. Epub 2012 Nov 24.
• Afshar-Oromieh A, Haberkorn U, Eder M, Eisenhut M, Zechmann CM. [68Ga]Gallium-labelled PSMA ligand as superior PET tracer for the diagnosis of prostate cancer: comparison with 18F-FECH. Eur J Nucl Med Mol Imaging. 2012 Jun;39(6):1085-6. doi: 10.1007/s00259-012-2069-0. Epub 2012 Feb 4. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; High-risk Prostate Cancer; PSMA-PET/CT; Radical Prostatectomy; Intermediate-risk Prostate Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UKD-26-001; COMBINE-P (Other Grant/Funding Number: EAU Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No