Prostate-first versus combined prostate and pelvic lymph node radiation dose escalation in PSMA PET–staged node-positive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 2/3 trial enrolls patients with PSMA PET–staged pelvic node‑positive (cN1M0) prostate cancer and combines long‑term androgen deprivation therapy with differing radiotherapy strategies. Participants are assigned to approaches that vary prostate treatment (ultrahypofractionated or SBRT-based prostate radiotherapy with or without an ablative boost) and pelvic nodal dose escalation (intermediate versus higher nodal doses). The study uses modern PSMA PET staging to ensure nodal disease is regional and delivers protocol-defined radiotherapy schedules to compare patterns of failure and disease control. Key outcomes include measures of regional control, distant metastasis‑free survival, and safety/toxicity of the different dose‑escalation strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate.
* Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.
* Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and/or PSMA PET/CT.
* No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.
* Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.
* Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy.
* Age ≥18 years.
* Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

* Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.
* Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.
* Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.
* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.
* History of castration-resistant prostate cancer.
* Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes.
* Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy.
* Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.

Where it's running

• Affidea Nu-Med, Center of Oncological Diagnostics and Therapy
  Zamość, Lublin Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Mateusz Bilski, MD, PhD — Affidea Nu-med Center of Oncological DIagnostics and Therapy
• Study coordinator: Mateusz Bilski, MD, PhD
• Email: bilskimat@gmail.com
• Phone: 048 84 535 99 10

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.