Combining radiotherapy with Lutetium-177 for prostate cancer treatment

Tolerability of Concurrent EBRT + Lu-PSMA for Node-positive Prostate Cancer (PROQURE-1)

This study is testing a new treatment for prostate cancer that combines radiation therapy with a special drug to see if it can better control tumors and improve patients' quality of life while reducing side effects.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: The Netherlands Cancer Institute (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Amsterdam and 1 other locations)
• Trial ID: NCT05162573 on ClinicalTrials.gov

What this trial studies

The PROQURE project aims to improve treatment outcomes for prostate cancer patients with node-positive disease by exploring a novel combination of external beam radiotherapy (EBRT) and Lutetium-177-PSMA radioligand therapy. This phase I study seeks to enhance tumor control while potentially reducing the need for prolonged androgen deprivation therapy (ADT), which is associated with significant toxicity. By targeting both macroscopic and microscopic tumor locations, the study hopes to achieve better disease-free survival rates and improve patients' quality of life. The approach is designed to be less toxic than current standard treatments, which often lead to high failure rates and adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 with histologically proven prostate cancer that is node-positive and has not yet been treated with EBRT.

Not a fit: Patients with prior treatments for prostate cancer or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide better tumor control and a reduced toxicity profile for patients with node-positive prostate cancer.

How similar studies have performed: While the combination of EBRT and Lutetium-177-PSMA therapy is innovative, similar approaches in targeting prostate cancer have shown promise, suggesting potential for success.

Eligibility 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.

Where this trial is running

Amsterdam and 1 other locations

• Netherlands Cancer Institute — Amsterdam, Netherlands (RECRUITING)
• UMC Utrecht — Utrecht, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Wouter V Vogel, MD, PhD — The Netherlands Cancer Institute
• Study coordinator: Wouter V Vogel, MD, PhD

Conditions: Prostatic Neoplasm, Lu-PSMA, Radiotherapy