Actively Recruiting
APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
Led by Umeå University · Updated on 2024-11-29
130
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical study is to to improve diagnosis, follow-up and treatment for patients with disseminated prostate cancer. The aim is to isolate tumour cells before image diagnostic methods find the metastases. In addition, investigators will use this method to characterise the tumour cells at the "single-cell" level to understand both the metastasis process, early resistance mechanisms and thus find new treatment targets to optimise individualised treatment. Research subjects who either have disseminated disease at diagnosis or have recurrence after surgery (with minimal dissemination) will be included. A control population of young men without cancer will also be recruited to distinguish tumor-specific changes from normal signals using these new methods.
CONDITIONS
Official Title
APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 81 years
- Venous blood vessels enabling apheresis
- ECOG performance status 0-2
- Normal potassium, calcium, and magnesium blood levels
- Testosterone above 1.7 nmol/L
- Hemoglobin above 90 g/L
- Platelet count above 50 x 10^9/L
- White blood cell count above 1 x 10^9/L
- Bilirubin below 1.4 times upper limit of normal (unless Gilbert's disease)
- ALAT or ASAT less than 2.4 times upper normal limit
- Creatinine less than 2 mg/dL (177 µmol/L)
- Ability to attend study visits as scheduled
- Planned for standard prostate cancer treatment in Sweden
- For metastatic prostate cancer (Arm 1): PSA above 100 ng/ml or skeletal metastases with high risk
- For PSA relapse after surgery (Arm 2): previous prostatectomy, PSA above 0.2 ng/ml, and PSA doubling time less than 18 months
- For healthy controls (Arm 3): no ongoing medication and no history of cancer
You will not qualify if you...
- Any other cancer disease or risk factors for apheresis treatment
- Weight below 50 kg
- Medical or surgical castration within last 6 months
- Antiandrogen treatment within last 6 months
- History of myocardial infarction, stroke, chronic heart failure, atrial fibrillation, or multiple deep vein thromboses
- Heart rate below 45 beats per minute
- Systolic blood pressure below 100 mmHg
- Ongoing diagnosed chronic inflammation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of surgical and perioperative sciences, Umeå university
Umeå, Norrlands University Hospital, Sweden, 90185
Actively Recruiting
Research Team
A
Andreas Josefsson, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here