Improving diagnosis and treatment for prostate cancer using blood cell analysis
APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer
This study is testing a new way to diagnose and treat metastatic prostate cancer by looking for cancer cells in the blood to see if it helps doctors understand the disease better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 81 Years |
| Sex | Male |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå, Norrlands University Hospital) |
| Trial ID | NCT06709326 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to enhance the diagnosis, follow-up, and treatment of patients with disseminated prostate cancer by isolating tumor cells from the blood before they can be detected through imaging. Participants will undergo apheresis to extract circulating tumor cells, which will then be characterized at the single-cell level to understand metastasis and resistance mechanisms. The study will include patients with metastatic prostate cancer and a control group of healthy young men to differentiate tumor-specific changes from normal signals. The research will also assess the mental health impact of undergoing apheresis.
Who should consider this trial
Good fit: Ideal candidates include patients with metastatic prostate cancer or those experiencing recurrence after surgery.
Not a fit: Patients with localized prostate cancer or those who do not meet the health status criteria for apheresis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and more personalized treatment options for patients with prostate cancer.
How similar studies have performed: While similar approaches have been explored, this specific method of isolating and characterizing circulating tumor cells in prostate cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 One 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 this trial is running
Umeå, Norrlands University Hospital
- Department of surgical and perioperative sciences, Umeå university — Umeå, Norrlands University Hospital, Sweden (Recruiting)
Study contacts
- Principal investigator: Andreas Josefsson, MD, PhD — Department of surgical and perioperative sciences, Urology, Umeå University
- Study coordinator: Andreas Josefsson, MD, PhD
- Email: andreas.josefsson@umu.se
- Phone: +46 70 3805395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.