EBRT + Lu-PSMA for N1M0 Prostate Cancer (NCT05162573) | Clinical Trial Compass
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 range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: from start of EBRT until 3 months after EBRT