High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 30, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique that targets a specific protein found in prostate cancer cells, known as Prostate Specific Membrane Antigen (PSMA). The goal is to improve personalized treatment for men with prostate cancer. The study is looking at two groups of patients: one group includes men who are scheduled for surgery (radical prostatectomy) to remove their prostate, and the other group includes men who have experienced a rise in prostate-specific antigen (PSA) levels after previous treatment, indicating a recurrence of cancer.

To be eligible for this trial, participants must be men aged 18 to 75 with confirmed prostate cancer. The first group needs to have a certain level of risk for cancer spreading to lymph nodes, while the second group should show signs of biochemical relapse. Participants can expect to undergo new imaging tests, which will help guide their treatment options. It’s important to note that the trial is currently recruiting participants, and those who have certain health issues or previous treatments may not be eligible. This study aims to provide valuable insights into more effective, personalized treatment strategies for prostate cancer.

Gender

MALE

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