EBRT + Lu-PSMA for N1M0 Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The PROQURE project aims to provide prostate cancer patients with more cure and better quality of life. The first part of this project (PROQURE-1) aims to explore an innovative combined modality treatment strategy for patients with node-positive prostate cancer (N1M0). The current standard of care for these patients, external beam radiotherapy (EBRT) of the prostate and regional pelvic nodes combined with 2-3 years androgen deprivation therapy (ADT), leads to suboptimal tumor control while inducing significant and potentially persistent toxicity. To overcome this, the current locoregional treatment is complemented with systemic Lutetium-177-PSMA radioligand therapy in a phase I study, with the aim to achieve better tumor control while potentially reducing or obviating ADT and its associated toxicity for future patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborators: Advanced Accelerator Applications; UMC Utrecht
• Treatments: 177Lu-PSMA-617

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 ≥ 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 during the study and for 6 months after the study drug administration; and

• Signed written informed consen

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, 177Lu-PSMA-617 or other;

• Reduced bone marrow reserve (Hb<6 mmol/L, Leukocytes<2.5 10E9/L, or Platelets<100 10E9/L not older than 1 month before start of EBRT);

• Reduced renal function (GFR < 60 not older than 1 month before start of EBRT);

• Reduced salivary gland function (history of prior salivary gland disease); or

• Miction problems requiring pre-treatment with ADT.