NCT03327675 High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
| NCT ID | NCT03327675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2017-09-22 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2017-09-22 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion criteria 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 * 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 Exclusion criteria 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 * 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
Contact & Investigator
Karolien Goffin, MD, PhD
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT03327675 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03327675 currently recruiting?
Yes, NCT03327675 is actively recruiting participants. Contact the research team at karolien.goffin@uzleuven.be for enrollment information.
Where is the NCT03327675 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT03327675 clinical trial?
NCT03327675 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Karolien Goffin, MD, PhD at UZ Leuven. The trial plans to enroll 188 participants.
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