Actively Recruiting
High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
188
Participants Needed
1
Research Sites
427 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with histologically confirmed invasive adenocarcinoma of the prostate
- For work-unit 1: Age under 75 years, intermediate to high risk of lymph node metastasis (≥5% risk), scheduled for radical prostatectomy with extended lymph node dissection
- For work-unit 2: Age 18 years or older, diagnosis of prostate cancer with biochemical relapse defined as two consecutive PSA values ≥0.2 ng/ml after initial curative treatment
- WHO performance status 0-1
You will not qualify if you...
- For work-unit 1: Pelvic lymph node involvement seen on multiparametric MRI
- Evidence of bone metastasis if PSA >20 ng/ml
- WHO performance status greater than 2
- Prior pelvic irradiation or radical prostatectomy
- Other malignancies except treated basal cell carcinoma within last 5 years
- Conditions that may prevent compliance with study protocol
- For work-unit 2: Serum testosterone level below 50 ng/ml
- Symptomatic metastases
- Local relapse on MRI
- PSA increase while on active hormone treatments (LHRH agonists/antagonists, anti-androgens, complete androgen blockade, estrogen-antioestrogen therapy)
- Previous cytotoxic chemotherapy for prostate cancer
- Treatment in past month with drugs affecting PSA levels (e.g., fluconazole, finasteride, corticosteroids)
- Cognitive or psychological conditions preventing informed consent or understanding of the trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZLeuven
Leuven, Belgium
Actively Recruiting
Research Team
K
Karolien Goffin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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