๐ฌIn plain words
What the trial is, and whether it could suit you
PRO-BOOST-N is a prospective, multicenter, randomized phase II/III clinical trial for patients with prostate cancer and pelvic lymph node involvement (cN1M0) confirmed by PSMA PET/CT, without distant metastatic disease.
Patients with PSMA PET-staged node-positive prostate cancer are potentially curable, but remain at substantial risk of distant progression despite contemporary treatment with radiotherapy, long-term androgen deprivation therapy, and, when appropriate, androgen receptor pathway inhibitors. The optimal way to intensify radiotherapy to the prostate and PSMA PET-positive pelvic lymph nodes remains uncertain in the era of modern molecular imaging.
All participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy backbone delivered in five fractions, combined with long-term systemic therapy according to contemporary clinical practice. The study uses a 2
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ18 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.
๐
What it tests
- Ultrahypofractionated Whole-Pelvis Radiotherapy
- SBRT-Based Prostate Radiotherapy (No Boost)
- Ablative Prostate Boost
- Intermediate Nodal Dose Escalation
- Higher Nodal Dose Escalation
Affidea Nu-Med, Center of Oncological Diagnostics and Therapy
Zamoลฤ, Poland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.
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