CompletedPhase 1

EBRT + Lu-PSMA for N1M0 Prostate Cancer

Netherlands14 participantsStarted 2021-12-20

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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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.

What they're measuring

Maximum tolerated dose (MTD)

Timeframe: from start of EBRT until 3 months after EBRT

Trial details

NCT IDNCT05162573

SponsorThe Netherlands Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-09