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

NCT07426094 | Recruiting Phase 2 DMC

• 1 other identifier: PRO-BOOST-N
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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 x 2 factorial randomized design to evaluate two treatment questions. The primary comparison evaluates whether prostate dose escalation improves metastasis-free survival compared with no additional prostate boost. Patients assigned to prostate boost receive one of three protocol-defined boost techniques: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT. If more than one prostate boost technique is available at the treating center and technically suitable for the patient, the boost technique is assigned by embedded subrandomization. The key secondary, hierarchically tested comparison evaluates nodal dose escalation by comparing two predefined dose levels to PSMA PET-positive pelvic lymph nodes. Organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm when required for patient safety and protocol compliance. The primary endpoint is metastasis-free survival (MFS) . Secondary endpoints include overall survival (OS), radiographic progression-free survival (rPFS), intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related adverse events graded according to CTCAE version 6.0, and patient-reported quality of life, including urinary, bowel, sexual, and global health domains. PRO-BOOST-N aims to determine the optimal radiotherapy intensification strategy for patients with PSMA PET-staged node-positive prostate cancer by prospectively evaluating prostate-directed and nodal-directed dose escalation within a modern, standardized radiotherapy platform.

Conditions

Prostate Cancer; Brachytherapy; Stereotactic Body Radiation Therapy (SBRT); Dose Escalation: Solid Tumors; Regionally Advanced Prostate Cancer

Keywords

Radiotherapy; Stereotactic Body Radiotherapy; SBRT; Brachytherapy; High-Dose-Rate Brachytherapy; Low-Dose-Rate Brachytherapy; Dose Escalation; Ultrahypofractionation; PSMA PET; Prostate-Specific Membrane Antigen; Metastasis-Free Survival; Nodal metastases; Metastases

Outcome Measures

Primary Outcomes (1)

• Metastasis-Free Survival (MFS)

  Metastasis-free survival is defined as the time from randomization to the first occurrence of distant metastatic disease or death from any cause, whichever occurs first. Distant metastases include non-regional lymph node, bone, or visceral metastases confirmed by PSMA PET imaging or other clinically indicated imaging modalities. Pelvic nodal progression alone does not constitute a metastasis-free survival event.

  Up to 10 years from randomization

Secondary Outcomes (16)

• Overall Survival (OS)

  Up to 10 years from randomization

• Radiographic Progression-Free Survival (rPFS)

  Up to 10 years from randomization

• Intraprostatic Local Control (iLC)

  Up to 10 years from randomization

• Regional Pelvic Nodal Control (rNC)

  Up to 10 years from randomization

• Time to Castration-Resistant Prostate Cancer (CRPC)

  Up to 10 years from randomization

Other Outcomes (5)

• Patterns of First Disease Progression

  Up to 10 years from randomization

• Hazard Ratio for Metastasis-Free Survival per 10 Gy Increase in Delivered Prostate EQD2

  Up to 10 years from randomization

• Impact of OAR-Driven Nodal Dose De-Escalation

  Up to 10 years from randomization

Study Arms (4)

Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose

EXPERIMENTAL

Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) with a simultaneous integrated boost to the prostate delivering 36.25 Gy in 5 fractions, without additional prostate boost. PSMA PET-positive pelvic lymph nodes receive an intermediate nodal dose escalation (27.75 Gy in 5 fractions). All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.

Radiation: Ultrahypofractionated Whole-Pelvis Radiotherapy; Radiation: SBRT-Based Prostate Radiotherapy (No Boost); Radiation: Intermediate Nodal Dose Escalation; Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Pathway Inhibitors (ARPIs)

Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose

EXPERIMENTAL

Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) with a simultaneous integrated boost to the prostate delivering 36.25 Gy in 5 fractions, without additional prostate boost. PSMA PET-positive pelvic lymph nodes receive a higher nodal dose escalation (30 Gy in 5 fractions), with protocol-defined organ-at-risk-driven dose de-escalation permitted if required. All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.

Radiation: Ultrahypofractionated Whole-Pelvis Radiotherapy; Radiation: SBRT-Based Prostate Radiotherapy (No Boost); Radiation: Higher Nodal Dose Escalation; Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Pathway Inhibitors (ARPIs)

Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose

EXPERIMENTAL

Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) to the prostate and pelvic lymph nodes, followed by ablative whole-gland prostate dose escalation. The prostate boost modality is assigned before main randomization: if two or more modalities are available and technically suitable, the modality is assigned by embedded subrandomization; if only one modality is feasible, that modality is prospectively assigned. Protocol-defined boost modalities include high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost. PSMA PET-positive pelvic lymph nodes receive an intermediate nodal dose escalation (27.75 Gy in 5 fractions). All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.

Radiation: Ultrahypofractionated Whole-Pelvis Radiotherapy; Radiation: Ablative Prostate Boost; Radiation: Intermediate Nodal Dose Escalation; Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Pathway Inhibitors (ARPIs)

Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose

EXPERIMENTAL

Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) to the prostate and pelvic lymph nodes, followed by ablative whole-gland prostate dose escalation. The prostate boost modality is assigned before main randomization: if two or more modalities are available and technically suitable, the modality is assigned by embedded subrandomization; if only one modality is feasible, that modality is prospectively assigned. Protocol-defined boost modalities include high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost. PSMA PET-positive pelvic lymph nodes receive a higher nodal dose escalation (30 Gy in 5 fractions), with protocol-defined organ-at-risk-driven dose de-escalation permitted if required. All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.

Radiation: Ultrahypofractionated Whole-Pelvis Radiotherapy; Radiation: Ablative Prostate Boost; Radiation: Higher Nodal Dose Escalation; Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Pathway Inhibitors (ARPIs)

Interventions

SBRT-Based Prostate Radiotherapy (No Boost) RADIATION

Definitive prostate radiotherapy delivered as a simultaneous integrated boost within the ultrahypofractionated whole-pelvis radiotherapy plan. The prostate receives a total dose of 36.25 Gy in 5 fractions without additional prostate boost beyond this dose.

Also known as: Definitive Prostate SBRT, Prostate SBRT 36.25 Gy

Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose; Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose

Intermediate Nodal Dose Escalation RADIATION

Dose escalation to PSMA PET-positive pelvic lymph nodes delivered using a simultaneous integrated boost technique within the ultrahypofractionated whole-pelvis radiotherapy plan. The prescribed nodal boost dose is 27.75 Gy in 5 fractions.

Also known as: PSMA PET-Guided Nodal Boost (Intermediate Dose), Pelvic Nodal SIB 27.75 Gy

Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose; Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose

Ultrahypofractionated Whole-Pelvis Radiotherapy RADIATION

Whole-pelvis external beam radiotherapy delivered using VMAT or IMRT techniques to elective pelvic lymph node volumes and the prostate. Treatment is prescribed as 25 Gy in 5 fractions and delivered with daily image guidance, serving as the standardized radiotherapy backbone for all study arms.

Also known as: Whole-Pelvis Radiotherapy (WPRT)

Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose; Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose; Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose; Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose

Higher Nodal Dose Escalation RADIATION

Dose escalation to PSMA PET-positive pelvic lymph nodes delivered using a simultaneous integrated boost technique within the ultrahypofractionated whole-pelvis radiotherapy plan. The prescribed nodal boost dose is 30 Gy in 5 fractions, with protocol-defined organ-at-risk-driven dose de-escalation permitted if required.

Also known as: PSMA PET-Guided Nodal Boost (High Dose), Pelvic Nodal SIB 30 Gy

Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose; Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose

Androgen Deprivation Therapy (ADT) DRUG

Androgen deprivation therapy administered as long-term systemic treatment in all study arms. ADT is delivered using luteinizing hormone-releasing hormone (LHRH) agonists or antagonists according to institutional practice and protocol-defined duration. ADT is initiated before or during radiotherapy and continued after completion of radiotherapy as specified in the study protocol.

Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose; Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose; Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose; Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose

Ablative Prostate Boost RADIATION

Ablative whole-gland prostate dose escalation delivered after completion of ultrahypofractionated whole-pelvis radiotherapy. The prostate boost modality is prospectively assigned before main randomization. If two or more protocol-defined boost modalities are available and technically suitable, the modality is assigned by embedded subrandomization; if only one modality is feasible, that modality is assigned as the single feasible option. Boost modalities include high-dose-rate brachytherapy (15 Gy in 1 fraction), low-dose-rate brachytherapy (110 Gy permanent implant), or single-fraction SBRT boost (15 Gy in 1 fraction).

Also known as: Prostate Boost Radiotherapy, Whole-Gland Prostate Boost

Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose; Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose

Androgen Receptor Pathway Inhibitors (ARPIs) DRUG

Androgen receptor pathway inhibitors may be administered in combination with androgen deprivation therapy according to contemporary clinical practice, local availability, and patient-specific considerations. The use of ARPIs is permitted but not randomized and includes approved agents targeting androgen receptor signaling.

Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose; Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose; Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose; Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility for this study is restricted to individuals with biological male sex, as prostate cancer is a sex-specific malignancy. Gender identity does not influence eligibility.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affidea Nu-med Center of Oncological DIagnostics and Therapy: lead

Study Sites (1)

Affidea Nu-Med, Center of Oncological Diagnostics and Therapy

Zamość, Lublin Voivodeship, 22-400, Poland

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mateusz Bilski, MD, PhD

  Affidea Nu-med Center of Oncological DIagnostics and Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Bilski, MD, PhD

CONTACT

048 84 535 99 10; bilskimat@gmail.com

Mateusz Bilski, MD,PhD

CONTACT

048 84 535 99 10; bilskimat@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: This is a prospective, multicenter, randomized, open-label phase II/III radiotherapy trial using a 2 x 2 factorial design. Participants are randomized to two intervention factors: (1) prostate dose escalation (no prostate boost vs ablative prostate boost) and (2) nodal dose escalation (intermediate vs higher dose to PSMA PET-positive pelvic lymph nodes). The factorial randomization creates four main treatment cells. Before main randomization, the eligible prostate boost modalities are documented; if two or more modalities are available and technically suitable, the A1 boost modality is assigned by embedded subrandomization and used only for patients randomized to prostate boost. Outcomes evaluate prostate-directed and nodal-directed dose escalation within a standardized ultrahypofractionated whole-pelvis radiotherapy platform.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 23, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2035
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting information will be available beginning 12 months after publication of the primary study results and will remain available for a period of 5 years thereafter.
• Access Criteria: Access to de-identified IPD will be granted to qualified researchers for approved research purposes following submission of a written proposal. Requests will be reviewed by the study steering committee for scientific merit, feasibility, and ethical appropriateness. A data use agreement will be required prior to data access.

Locations

PL (1)