APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
Recruiting · NCT06709326 · Interventional (participants receive a specific treatment) · Lead sponsor: Umeå University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- The patient (arm 1 and arm 2) must have a health status that minimises the already low risks of the apheresis treatment, have the logistical possibilities to come to the visits according to the study and be planned for treatment according to standard treatment in Sweden today.
- For arm 1, 2 and 3:
- Venous blood vessels enabling apheresis
- ECOG-performance status 0-2
- Concentration of av potassium, calcium and magnesium in blood within normal range
- Testosterone\>1,7 nmol/L
- Hb\>90 g/L
- TPK \>50x10exp9 /L
- LPK \>1x10exp9 /L
- Bilirubin \<1,4 x upper limit for normal (unless the subject suffers from Gilberts disease)
- ALAT or ASAT \<2,4 x above limit for normal
- Creatinine \<2 mg/dL (\<177µmol/L)
- Additional inclusion criteria for Arm 1 - Metastatic prostate cancer
- ne of the following criteria:
- PSA \>100ng/ml
- Skeletal metastases with high risk of prostate cancer (regardless of PSA-value)
- Additional inclusion criteria for Arm 2 - PSA relapse after operation
- All of the three following criteria must be fulfilled:
- Prostatectomy
- PSA \>0.2ng/ml
- PSA doubling time \<18 months (according to www.mskcc.org/nomograms/prostate/psa\_doubling\_time)
- Additional inclusion criteria for Arm 3 - Healthy research subjects (control group)
- All of the following two criteria must be fulfilled:
- Previously healthy (no ongoing medication)
- No history of cancer
Exclusion criteria
- for arm 1, 2 and 3:
- Overall, research subjects must not have any other cancer disease or risk factors for undergoing apheresis treatment
- Weight \<50 kg
- Medical castration last 6 months (or previous surgical castration)
- Antiandrogen treatment in the last 6 months
- Previous myocardial infarction, stroke, chronic heart failure, atrial fibrillation or multiple deep vein thromboses
- Heart rate \<45
- Systolic blood pressure below 100
- Ongoing diagnosed chronic inflammation
Where it is running
1 location listed.
- Department of surgical and perioperative sciences, Umeå university - Umeå, Norrlands University Hospital, Sweden