NCT05162573CompletedPhase 1
EBRT + Lu-PSMA for N1M0 Prostate Cancer
Tolerability of Concurrent EBRT + Lu-PSMA for Node-positive Prostate Cancer (PROQURE-1)
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 7 Oct 2021
- Start date
- 20 Dec 2021
- Primary completion date
- 9 Sept 2025
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT05162573
- EU CT number
- 2024-514168-15-00
- EudraCT number
- 2020-005577-27
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From 20 Dec 2021 to the primary completion date, 9 Sept 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to adhere to radiation safety measures in hospital or at home;
- 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 salivary gland function (history of prior salivary gland disease); or
- Miction problems requiring pre-treatment with ADT.
Lab values
- 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);
Other
- Inability to comply to study procedures;
- Inability to undergo the required biodistribution scans;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.