High Risk Prostate Cancer
Conditions
Keywords
High risk Prostate cancer, Radical Prostatectomy, PSMA, Theranostics, radionuclide therapy
Brief summary
This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.
Interventions
DRUGTb-PSMA-I&T (Tb-PSMA)
Terbium-161 produce beta emission with the addition of Auger electrons which have higher linear energy transfer and a very short range. By that it has the potential to improve local and distal (micro-metastatic disease) efficacy with a similar safety profile. It will be given to patients with high risk locally advanced prostate cancer prior to Radical prostatectomy
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male aged 18 years and older. * Patients with high-risk localized prostate cancer (cT3/4 and/or Gleason score ≥ eight and/or prostate biopsy or PSA ≥ 20 ng/dl) * High PSMA expression was confirmed according to PROMISE V2 8 * Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or lower and a life expectancy of \> 10 years.
Exclusion criteria
* Platelet count lower than 150×103/µl * white blood cell count lower than 4×103/µl, * haemoglobin concentration lower than 12mg/dl. * albumin concentration lower than 3.5 g/dl. * glomerular filtration rate (GFR) lower than 40 mL/min. * usage of nephrotoxic drugs * distant metastatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tb-PSMA adverse effects measured by CTCAE v4.0 and number of surgical complications - measured by the Clavien-Dindo Classification (2009) | 1 year | — |
| Surgical and clinical safety | 1 year | The primary outcome is the safety of administering Tb-PSMA before radical prostatectomy, its impact on intra- and post-operative clinical course according to the Clavien-Dindo Classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate oncological outcomes as measured by number of patients with positive surgical margins and number of patients who achieved biochemical complete response | 3 months | Secondary outcomes include the immediate response to treatment in terms of biochemical response. A post-surgical prostate specific antigen above 0.1 ng/ml is considered biochemical failure. |
Countries
Israel
Contacts
Primary ContactShay Golan, MD
Backup ContactHana Burnstein, MD
Outcome results
None listed