Status:
RECRUITING
High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 ...
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, radiother...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT03327675
Start Date
September 22 2017
End Date
December 1 2025
Last Update
July 3 2024
Active Locations (1)
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1
UZLeuven
Leuven, Belgium