APACA-Apheresis/acoustophoresis and Molecular Characterization of Prostate Cancer

Launched by UMEÅ UNIVERSITY · Nov 26, 2024

Keywords

ClinConnect Summary

The clinical trial titled "APACA" is focused on improving how we diagnose and treat prostate cancer, especially in patients whose cancer has spread. The researchers aim to isolate cancer cells from the blood before they can be detected by imaging tests. By studying these cells closely, they hope to gain insights into how the cancer spreads and develops resistance to treatments, which could lead to more personalized and effective therapies.

To participate in this trial, men aged between 65 and 84 with advanced prostate cancer or those experiencing a return of cancer after surgery may be eligible, as long as they meet certain health criteria. There is also a control group of healthy young men who will help differentiate between normal and cancer-related changes in the body. Participants can expect to undergo a procedure called apheresis, which collects blood cells for analysis, along with regular visits for monitoring. Overall, this study aims to enhance our understanding and treatment of prostate cancer to better support patients and their families.

Gender

MALE

Eligibility 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