Prostate CancerNCT03327675
High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
A study testing 68Ga-PSMA (HBED-CC) PET in people with Prostate Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. 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?
- 68Ga-PSMA (HBED-CC) PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Sep 2017to Dec 2025
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Work-unit 1
- age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
- a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
- scheduled to undergo radical prostatectomy with extended lymph node dissection
- Work-unit 2
- histologically proven diagnosis of prostate cancer
Show all 9Show fewer
- biochemical relapse (two consecutive PSA≥0.2 ng/ml) of prostate cancer following radical local prostate treatment
- WHO performance state 0-1
- age > 18 years old
Who cannot join
- Work-unit 1
- involvement of pelvic lymph nodes assessed by multi-parametric MRI
- evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml)
- WHO performance status > 2
- previous pelvic irradiation or radical prostatectomy.
- other malignancy except adequately treated basal cell carcinoma of the skin diagnosed during the last 5 years
Show all 15Show fewer
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Work-unit 2
- serum testosterone level <50ng/ml
- symptomatic metastases
- local relapse on MRI
- PSA rise while on active treatment with LHRH-agonist, LHRH-antagonist, Anti-androgen, Complete androgen blockade, Oestrogen-antioestrogen therapy
- previous treatment with cytotoxic agent for PCa
- treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids,…)
- disorder precluding understanding of trial information or informed consent
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven
Leuven
Karolien Goffin, MD-PhD, +3216343715, karolien.goffin@uzleuven.be
About this study
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.
Read the detailed description
Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.
The study consists of 2 work units (WU):
Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA (HBED-CC) PET
- Keywords
- prostate-specific membrane antigen, Lymph Node Dissection, Prostatectomy, Positron-Emission Tomography
- 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-CC) PETOther
68Ga-PSMA PET/MR
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA PET/MR | Experimental | Hybrid 68Ga-PSMA PET/MR scan Receives: Other: 68Ga-PSMA (HBED-CC) PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
Assessment of the sensitivity, specificity, positive and negative predictive
Measured: through study completion, an average of 2 year
Secondary outcomes (3)
The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.
Correlation between tracer uptake and pathology Gleason score
Measured: through study completion, an average of 2 year
Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.
Assessment of the sensitivity, specificity, positive and negative predictive value
Measured: through study completion, an average of 2 year
The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.
Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start22 Sep 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karolien Goffin, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327675
- Sponsor's protocol ID
- S59428
- Other IDs
- 2016-003089-14, 2016
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmadi Bidakhvidi N, Lara Jimenez E, Leupe H, Jentjens S, Baldewijns M, De Schepper M, Laenen A, Devos G, Giesen A, Koole M, Deroose CM, Everaerts W, Joniau S, Goffin K. Interreader agreement of intraprostatic prostate cancer detection, local extension and staging using [18F]PSMA-1007 PET and whole-mount radical prostatectomy specimens. EJNMMI Res. 2026 Jan 9;16(1):11. doi: 10.1186/s13550-025-01359-8.
PubMed 41511587Draulans C, De Roover R, van der Heide UA, Kerkmeijer L, Smeenk RJ, Pos F, Vogel WV, Nagarajah J, Janssen M, Isebaert S, Maes F, Mai C, Oyen R, Joniau S, Kunze-Busch M, Goffin K, Haustermans K. Optimal 68Ga-PSMA and 18F-PSMA PET window levelling for gross tumour volume delineation in primary prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1211-1218. doi: 10.1007/s00259-020-05059-4. Epub 2020 Oct 6.
PubMed 33025093
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03327675
- Acronym / sponsor ID
- S59428
- Conditions
- Prostate Cancer
- Keywords
- prostate-specific membrane antigen, Lymph Node Dissection, Prostatectomy, Positron-Emission Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Oct 2017 (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.
This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.
Detailed description
Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.
The study consists of 2 work units (WU):
Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA PET/MR | Experimental | Other: 68Ga-PSMA (HBED-CC) PETHybrid 68Ga-PSMA PET/MR scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Work-unit 1
- age < 75 years of age, with histologically proven invasive adenocarcinoma of the prostate
- a risk of equal or more than 5% of lymph node metastasis (intermediate to high risk disease), according to the Briganti nomogram (1)
- scheduled to undergo radical prostatectomy with extended lymph node dissection
- Work-unit 2
Key exclusion criteria (15 listed)
- Work-unit 1
- involvement of pelvic lymph nodes assessed by multi-parametric MRI
- evidence for bone metastasis assessed by bone scan (if PSA > 20 ng/ml)
- WHO performance status > 2
- previous pelvic irradiation or radical prostatectomy.
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-CC) PET68Ga-PSMA PET/MR | Other | 68Ga-PSMA PET/MR |
Primary outcome
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.
Time frame: through study completion, an average of 2 year
Assessment of the sensitivity, specificity, positive and negative predictive
3 secondary outcomes
The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.
Time frame: through study completion, an average of 2 year
Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.
Time frame: through study completion, an average of 2 year
The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 41511587Ahmadi Bidakhvidi N, Lara Jimenez E, Leupe H, Jentjens S, Baldewijns M, De Schepper M, Laenen A, Devos G, Giesen A, Koole M, Deroose CM, Everaerts W, Joniau S, Goffin K. Interreader agreement of intraprostatic prostate cancer detection, local extension and staging using [18F]PSMA-1007 PET and whole-mount radical prostatectomy specimens. EJNMMI Res. 2026 Jan 9;16(1):11. doi: 10.1186/s13550-025-01359-8.
- Derived from this study: PubMed 33025093Draulans C, De Roover R, van der Heide UA, Kerkmeijer L, Smeenk RJ, Pos F, Vogel WV, Nagarajah J, Janssen M, Isebaert S, Maes F, Mai C, Oyen R, Joniau S, Kunze-Busch M, Goffin K, Haustermans K. Optimal 68Ga-PSMA and 18F-PSMA PET window levelling for gross tumour volume delineation in primary prostate cancer. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1211-1218. doi: 10.1007/s00259-020-05059-4. Epub 2020 Oct 6.
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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.
Karolien Goffin, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-PSMA (HBED-CC) PET in people with Prostate Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karolien Goffin, MD, PhD (003216343714, karolien.goffin@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2. (time frame: through study completion, an average of 2 year). 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 NCT03327675, 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 3 Jul 2024.