prostate cancer
Conditions
Interventions
Standard of care treatment (EBRT of prostate and pelvic nodes with concurrent
ADT) is complemented with 1/2 concurrent cycle dose-escalated Lu-PSMA in week 2
(and 4).
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically proven prostate cancer; - cT2-4, partly determined by MRI; - N1, determined by LND/SNP and/or PSMA PET/CT; - iM0, determined by PSMA PET/CT; - Accepted for curative intent treatment with EBRT of the prostate and regional nodes + 3y ADT; - Visually PSMA-positive primary tumor and nodes, largest lesion higher or equal to average liver uptake; - WHO performance score 0-1; - Age > 18 years; - For patients who have partners of childbearing potential: Willingness to use a method of birth control with adequate barrier protection as described in section 4.4 during the study and for 6 months after the study drug administration; and - Signed written informed consent.
Exclusion criteria
Exclusion criteria: - Inability to comply to study procedures; - Inability to adhere to radiation safety measures in hospital or at home; - Inability to undergo the required biodistribution scans; - Prior or current malignant disease with potential impact on treatment outcome or survival; - Prior treatment with EBRT; - Prior treatment with ADT, already initiated >1 month before the start of EBRT; - Prior treatment with radionuclide therapies, Lu-PSMA or other; - Reduced bone marrow reserve (Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The maximum tolerated dose (MTD) of the 4 selected doses of Lu-PSMA (3, 6, 9 or 2x7.4 GBq) when administered in combination with EBRT. Dose-limiting toxicity (DLT) will be acute toxicity CTCAE v 5.0 grade 3 of any type occurring from start of EBRT until 3 months after, determined to be related to study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: late toxicity according to CTCAE v 5.0 at 6 months, PSA response at 6 months, quality of life according to EORTC QLQ-C30 and -PR25 questionnaires, combined dosimetry based on added dose distributions from EBRT+Lu-PSMA, and in vivo pharmacokinetics of Lu-PMSA during EBRT based on biodistribution imaging and blood samples. | — |
Countries
Netherlands
Outcome results
None listed