Clinical trial · Interventional
EBRT + Lu-PSMA for N1M0 Prostate Cancer
Tolerability of Concurrent EBRT + Lu-PSMA for Node-positive Prostate Cancer (PROQURE-1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-PSMA-617 | Drug | Lutetium (177lu) Vipivotide Tetraxetan | ALIAS |
| EBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- EBRT + 3 GBq Lu-PSMA
- interventionNames
- Drug: 177Lu-PSMA-617
- Radiation: EBRT
- type
- EXPERIMENTAL
- label
- EBRT + 6 GBq Lu-PSMA
- interventionNames
- Drug: 177Lu-PSMA-617
- Radiation: EBRT
- type
- EXPERIMENTAL
- label
- EBRT + 9 GBq Lu-PSMA
- interventionNames
- Drug: 177Lu-PSMA-617
- Radiation: EBRT
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDvan der Sar ECA, Braat AJAT, van der Voort-van Zyp JRN, van der Veen BS, van Leeuwen PJ, de Vries-Huizing DMV, Hendrikx JMA, Lam MGEH, Vogel WV. Tolerability of concurrent external beam radiotherapy and [177Lu]Lu-PSMA-617 for node-positive prostate cancer in treatment naive patients, phase I study (PROQURE-I trial). BMC Cancer. 2023 Mar 23;23(1):268. doi: 10.1186/s12885-023-10725-5. PMID 36959540