What is PRO-BOOST-N studying for prostate cancer?

PRO-BOOST-N is studying whether increasing radiation doses to the prostate and/or pelvic lymph nodes improves outcomes for patients with node-positive prostate cancer detected by PSMA PET imaging. The trial evaluates different radiotherapy strategies combined with systemic therapy to find the best approach for controlling the disease. It is sponsored by Affidea Nu-med Center of Oncological Diagnostics and Therapy.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 years or older with prostate cancer involving pelvic lymph nodes but no distant metastases may be eligible. Participants must be suitable for radiotherapy and systemic therapy, have good general health, and have not received prior definitive local treatment for prostate cancer. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

MALE

ID07426094

PRO-BOOST-N Phase IIIII Trial Testing Prostate and Pelvic Lymph Node Radiation Dose Escalation in Node-Positive Prostate Cancer Using Ultrahypofractionated Radiotherapy

Led by Affidea Nu-med Center of Oncological DIagnostics and Therapy · Updated on 2026-07-21

600

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the best way to intensify radiotherapy for patients with prostate cancer that has spread to pelvic lymph nodes but not to distant sites. This trial focuses on patients confirmed by PSMA PETCT imaging to have node-positive prostate cancer without distant metastases. The study seeks to determine if increasing the radiation dose to the prostate, the pelvic lymph nodes, or both improves long-term outcomes, including preventing the spread of cancer and enhancing survival. Participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy regimen delivered in five treatments, combined with long-term androgen deprivation therapy, with optional androgen receptor pathway inhibitors. The trial uses a 2 x 2 factorial design to compare four groups prostate radiotherapy without additional boost with intermediate or higher nodal radiation doses, and prostate radiotherapy with an additional ablative prostate boost using high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost combined with either intermediate or higher nodal doses. The boost technique is assigned based on availability and suitability per participant. Throughout the study, participants undergo clinical assessments, PSA and testosterone monitoring, toxicity reporting, and patient-reported quality of life evaluations focused on urinary, bowel, sexual, and global health domains. Imaging with PSMA PET is used at baseline and upon suspected progression to assess disease status. The main outcome measured is metastasis-free survival over up to 10 years, with additional outcomes including overall survival, progression-free survival, local and nodal control, time to castration-resistant cancer, treatment side effects, and quality of life. The study includes long-term follow-up to capture late events and treatment effects.

CONDITIONS

Brief Title

PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Histologically confirmed adenocarcinoma of the prostate.
Prostate cancer with clinically positive pelvic lymph nodes (cN1) without distant metastatic disease.
Pelvic lymph node involvement limited to regional pelvic lymph nodes as assessed by imaging.
No evidence of distant metastases including non-regional nodes, bone, or visceral sites.
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.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Adequate organ function for radiotherapy and systemic therapy.
Age 18 years or older.
Ability to understand and sign informed consent.

You will not qualify if you...

Evidence of distant metastatic disease including non-regional lymph nodes, bone, or visceral metastases.
Prior definitive local therapy for prostate cancer such as prostatectomy, whole-gland radiotherapy, or brachytherapy.
Prior pelvic radiotherapy overlapping planned treatment areas.
Prior systemic therapy for prostate cancer other than allowed neoadjuvant androgen deprivation therapy.
History of castration-resistant prostate cancer.
Concurrent malignancy requiring active treatment except non-melanoma skin cancer or cancers unlikely to interfere with study outcomes.
Severe uncontrolled comorbidities preventing safe therapy.
Any condition that may interfere with safety or study compliance as judged by investigator.

Research Team

Mateusz Bilski, MD, PhD

Mateusz Bilski, MD,PhD

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