A Phase 2/3 interventional study of Ultrahypofractionated Whole-Pelvis Radiotherapy and SBRT-Based Prostate Radiotherapy (No Boost) in Prostate Cancer, Brachytherapy and Stereotactic Body Radiation Therapy (SBRT), sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy. Recruiting at 1 site in Poland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy · Phase 2/3, Interventional, and Treatment
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.
Disease Background and Unmet Clinical Need Prostate cancer with pelvic lymph node involvement (cN1M0) represents a clinically challenging disease state characterized by a substantial risk of subsequent metastatic progression and prostate cancer-specific mortality. Historically, patients with node-positive disease were frequently considered to harbor occult systemic spread and were often managed with androgen deprivation therapy (ADT) alone. This treatment paradigm was largely driven by limitations in imaging sensitivity and by the perception that regional nodal involvement inevitably reflected disseminated disease.
Over the past two decades, accumulating clinical evidence has fundamentally altered this view. Multiple retrospective analyses, population-based studies, and prospective randomized trials have demonstrated that definitive local-regional radiotherapy combined with long-term ADT can achieve durable disease control and improve survival outcomes in selected patients with node-positive prostate cancer. These findings have established combined radiotherapy and systemic therapy as a contemporary standard of care for cN1 disease treated with curative intent.
Despite these advances, outcomes remain heterogeneous. Even with modern multimodality treatment, a substantial proportion of patients experience disease progression, most commonly manifesting as distant metastatic spread. This persistent failure pattern highlights an unmet clinical need to optimize local-regional treatment strategies and to better define the relative contributions of prostate-directed and nodal-directed radiotherapy dose escalation to long-term disease control.
Transformation of Staging in the PSMA PET Era The widespread clinical adoption of prostate-specific membrane antigen positron emission tomography (PSMA PET) has transformed staging and risk stratification in prostate cancer. PSMA PET offers superior sensitivity and specificity compared with conventional imaging for the detection of nodal and distant metastatic disease. This has led to stage migration, particularly among patients previously classified as node-negative on conventional imaging who are now identified as having limited pelvic nodal involvement.
As a result, the contemporary population of patients classified as cN1M0 based on PSMA PET represents a biologically and clinically distinct cohort compared with historical node-positive populations. Many of these patients harbor small-volume nodal disease that would previously have remained undetected. Consequently, existing evidence guiding radiotherapy dose prescription and target volume selection, largely derived from the pre-PSMA era, may not be directly applicable to current clinical practice.
Importantly, while PSMA PET improves detection of nodal disease, it does not define the optimal therapeutic response. The identification of pelvic nodal metastases raises critical questions regarding treatment intensification: whether improved outcomes are best achieved through more aggressive treatment of the primary prostate tumor, through escalation of dose to involved lymph nodes, or through a combined strategy addressing both compartments.
Biological Rationale for Local-Regional Disease Control From a biological perspective, prostate cancer progression is increasingly understood as a dynamic process in which the primary tumor and regional nodal metastases may serve as sources of further metastatic dissemination. In this context, effective control of both intraprostatic disease and regional nodal deposits may reduce subsequent disease spread and delay or prevent the emergence of castration-resistant disease.
Durable intraprostatic disease control has consistently been associated with improved long-term outcomes across multiple prostate cancer risk groups. Dose escalation to the prostate has been shown to improve biochemical control, local control, and, in selected analyses, metastasis-free and overall survival. These benefits have been demonstrated using a variety of techniques, including conventionally fractionated radiotherapy, moderate and ultrahypofractionation, stereotactic body radiotherapy (SBRT), and brachytherapy boost approaches.
In node-positive prostate cancer specifically, emerging real-world and propensity score-matched analyses suggest that intensified prostate-directed radiotherapy may exert an important influence on systemic disease control. Patients receiving high biologically effective doses to the prostate, particularly through brachytherapy boost techniques, may experience improved metastasis-free survival even in the presence of pelvic nodal disease. These observations form the biological foundation of the central hypothesis underlying PRO-BOOST-N.
Prostate Dose Escalation as the Primary Hypothesis The primary hypothesis of PRO-BOOST-N is that durable intraprostatic tumor control is a major determinant of long-term systemic disease suppression in patients with PSMA PET-staged node-positive prostate cancer. According to this hypothesis, effective treatment of the primary tumor may reduce the reservoir of clonogenic cells capable of seeding distant metastases, thereby improving metastasis-free survival.
PRO-BOOST-N is designed to prospectively test this hypothesis in a randomized setting by comparing contemporary SBRT-based definitive prostate radiotherapy without additional boost to ablative prostate dose escalation delivered using established high-dose techniques.
Uncertainty and Rationale Regarding Nodal Dose Escalation In contrast to the relatively consistent signal supporting prostate dose escalation, the role of aggressive dose escalation to involved pelvic lymph nodes remains uncertain. While the biological rationale for nodal ablation is compelling, clinical evidence remains heterogeneous. Retrospective series have demonstrated the technical feasibility and safety of delivering escalated doses to involved pelvic lymph nodes using modern intensity-modulated techniques, including simultaneous integrated boost approaches.
However, the incremental clinical benefit of escalating nodal dose beyond moderate biologically effective levels has not been consistently demonstrated. Some analyses suggest a dose-response relationship up to approximately 55-60 Gy EQD2, with a potential plateau thereafter. Other studies have not demonstrated an independent association between nodal dose and survival outcomes when prostate dose and systemic therapy are taken into account. In addition, aggressive nodal dose escalation may increase the risk of gastrointestinal and genitourinary toxicity, particularly in hypofractionated or ultrahypofractionated regimens.
Given these uncertainties, PRO-BOOST-N incorporates nodal dose escalation as a key secondary objective, evaluated hierarchically after the primary prostate dose escalation comparison. This design reflects both biological plausibility and the current state of clinical evidence, while minimizing the risk of overinterpreting potentially marginal effects.
Rationale for Ultrahypofractionated Whole-Pelvis Radiotherapy Prostate cancer exhibits a low alpha/beta ratio, making it suitable for hypofractionated and ultrahypofractionated radiotherapy schedules. Advances in treatment planning, image guidance, and motion management have enabled delivery of large fraction sizes with acceptable toxicity profiles. Emerging clinical data suggest that whole-pelvis radiotherapy can be delivered in a limited number of fractions when modern techniques are applied, including in high-risk and node-positive settings.
An ultrahypofractionated whole-pelvis radiotherapy platform offers several advantages. It provides a standardized treatment backbone that minimizes variability in fractionation and overall treatment time, improves patient convenience, and facilitates protocol adherence across multiple centers. It also enables direct comparison of prostate and nodal dose escalation strategies within a unified fractionation framework.
Study Design and Overall Structure PRO-BOOST-N is a prospective, multicenter, randomized phase II/III clinical trial designed to evaluate the relative and combined impact of prostate-directed and nodal-directed radiotherapy dose escalation in patients with PSMA PET-staged node-positive (cN1M0) prostate cancer. All eligible patients undergo mandatory baseline PSMA PET/CT to confirm pelvic lymph node involvement and exclude distant metastatic disease. Multiparametric magnetic resonance imaging of the prostate is strongly recommended to support local staging and target delineation.
All enrolled patients receive a standardized ultrahypofractionated external beam radiotherapy backbone consisting of whole-pelvis radiotherapy delivered in five fractions. This backbone includes elective pelvic nodal volumes and the prostate and is delivered using modern intensity-modulated techniques with daily image guidance. All patients receive long-term ADT as the systemic therapy backbone, with optional use of androgen receptor pathway inhibitors according to contemporary clinical practice and local availability.
Randomization Framework and Treatment Factors The trial employs a 2 x 2 factorial randomized design incorporating two independent treatment factors. The first factor evaluates prostate dose escalation strategy and constitutes the primary randomized comparison. Patients are assigned to receive either contemporary SBRT-based definitive prostate radiotherapy without additional boost or ablative prostate dose escalation delivered using one of three protocol-defined modalities: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost.
Before the main factorial randomization, the prostate boost modality eligibility set is documented for each patient. If two or more prostate boost modalities are available at the enrolling center and technically suitable for the patient, embedded subrandomization is performed among the eligible modalities in an equal ratio. If only one prostate boost modality is available and technically suitable, that modality is prospectively assigned as the single feasible modality. The assigned prostate boost modality is used only if the patient is randomized to the prostate boost arm.
The second factor evaluates nodal dose escalation strategy and constitutes a key secondary, hierarchically tested comparison. Patients are randomized to receive one of two predefined dose levels to PSMA PET-positive pelvic lymph nodes, corresponding to intermediate versus higher biologically effective doses. Nodal boost doses are delivered using a simultaneous integrated boost approach within the ultrahypofractionated whole-pelvis radiotherapy plan. Protocol-defined organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm to ensure patient safety and feasibility.
Systemic Therapy Integration and Real-World Relevance All patients enrolled in PRO-BOOST-N receive long-term androgen deprivation therapy in accordance with contemporary standards of care. The use of androgen receptor pathway inhibitors is permitted and encouraged based on clinical indications, local availability, and patient comorbidities. Systemic therapy is not randomized, reflecting real-world practice, but planned use of androgen receptor pathway inhibitors is recorded at baseline and incorporated into stratification and exploratory analyses.
This approach ensures that the trial evaluates radiotherapy dose escalation strategies within the context of modern systemic treatment, enhancing the external validity and clinical relevance of the results.
Endpoints and Outcome Assessment The primary endpoint of PRO-BOOST-N is metastasis-free survival, defined as the time from randomization to the occurrence of distant metastatic disease or death from any cause. Pelvic nodal progression alone does not constitute a metastasis-free survival event and is analyzed separately under regional control endpoints.
Secondary endpoints include overall survival, radiographic progression-free survival assessed primarily using PSMA PET imaging, intraprostatic local control, regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, acute and late treatment-related toxicity graded according to CTCAE version 6.0, and patient-reported outcomes assessing urinary, bowel, sexual, and global quality of life.
Imaging, Follow-up, and Failure Pattern Characterization PSMA PET imaging is central to both baseline staging and assessment of disease progression. Imaging is performed at baseline and at the time of suspected progression based on PSA kinetics or clinical findings. This strategy enables precise localization and characterization of disease recurrence and allows differentiation between local recurrence, regional nodal progression, oligometastatic dissemination, and polymetastatic disease.
Patients are followed longitudinally with standardized clinical assessments, PSA and testosterone monitoring, toxicity reporting, and patient-reported outcome measures. Long-term follow-up is planned to capture late disease events, late toxicity, and survival outcomes.
Statistical Philosophy and Phase II/III Transition PRO-BOOST-N is designed as a seamless phase II/III trial. The initial phase II component focuses on feasibility, treatment compliance, and early safety. Upon meeting predefined criteria, the trial transitions seamlessly into the phase III component without interruption of accrual. Hierarchical testing preserves statistical power for the primary hypothesis while allowing formal evaluation of the key secondary hypothesis.
Expected Clinical and Scientific Impact By prospectively and hierarchically evaluating prostate-first versus combined prostate and nodal dose escalation strategies within a PSMA PET-guided and ultrahypofractionated radiotherapy framework, PRO-BOOST-N seeks to address one of the most important unresolved questions in contemporary prostate cancer management. The results of this trial have the potential to inform clinical practice, refine guideline recommendations, and optimize treatment individualization for patients with node-positive prostate cancer in the PSMA PET era.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 600 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Affidea Nu-med Center of Oncological DIagnostics and Therapy is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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)
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)
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)
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
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
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
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
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.
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.
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.
Time frame: Up to 10 years from randomization
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.
Time frame: Up to 10 years from randomization
Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival is defined as the time from randomization to radiographic disease progression or death from any cause, whichever occurs first. Radiographic progression is assessed primarily using PSMA PET imaging and includes local, regional nodal, or distant disease progression according to protocol-defined criteria.
Time frame: Up to 10 years from randomization
Intraprostatic Local Control (iLC)
Intraprostatic local control is defined as the absence of radiographic or histologically confirmed recurrence within the prostate gland after completion of radiotherapy, assessed using PSMA PET imaging, multiparametric MRI, or biopsy when clinically indicated.
Time frame: Up to 10 years from randomization
Regional Pelvic Nodal Control (rNC)
Regional pelvic nodal control is defined as the absence of progression or recurrence within pelvic lymph node regions after radiotherapy. Pelvic nodal progression is assessed using PSMA PET imaging or other clinically indicated imaging modalities.
Time frame: Up to 10 years from randomization
Time to Castration-Resistant Prostate Cancer (CRPC)
Time to castration-resistant prostate cancer is defined as the time from randomization to the development of castration-resistant disease, according to standard clinical and biochemical criteria, while maintaining castrate levels of testosterone.
Time frame: Up to 10 years from randomization
Time to Next Systemic Therapy (TTNS)
Time to next systemic therapy is defined as the time from randomization to initiation of the first subsequent systemic anticancer treatment beyond protocol-defined androgen deprivation therapy, including chemotherapy or additional hormonal agents.
Time frame: Up to 10 years from randomization
Acute treatment-related adverse events
Acute treatment-related adverse events is assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 and includes adverse events occurring from the start of radiotherapy up to 90 days after completion of radiotherapy. Time Frame: From start of radiotherapy to 90 days after completion of radiotherapy
Time frame: Up to 90 days after completion of radiotherapy
Late treatment-related adverse events
Late treatment-related adverse events is assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 and includes adverse events occurring more than 90 days after completion of radiotherapy. Time Frame: More than 90 days after completion of radiotherapy up to 10 years from randomization
Time frame: Up to 10 years after completion of radiotherapy
Time to Polyprogressive or Polyrecurrent Disease (TTPD)
Time to polyprogressive or polyrecurrent disease is defined as the time from randomization to first documentation of polyprogressive or polyrecurrent disease, defined as the development of more than five new and/or regrowing metastatic lesions (regional and/or non-regional) or widespread metastatic disease precluding further metastasis-directed therapy.
Time frame: Up to 10 years from randomization
Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Domain Score
Change from baseline in urinary quality of life assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary domain. The EPIC-26 urinary domain is scored on a 0-100 scale, where higher scores indicate better urinary function and fewer urinary symptoms.
Time frame: Up to 10 years from randomization
EPIC-26 Bowel Domain Score
Change from baseline in bowel quality of life assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel domain. Scores range from 0 to 100, with higher scores indicating better bowel function and fewer bowel-related symptoms.
Time frame: From baseline to 10 years after randomization
EPIC-26 Sexual Domain Score
Change from baseline in sexual function assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) sexual domain. Scores range from 0 to 100, with higher scores indicating better sexual function.
Time frame: From baseline to 10 years after randomization
International Prostate Symptom Score (IPSS)
Change from baseline in lower urinary tract symptoms assessed using the International Prostate Symptom Score (IPSS). The IPSS ranges from 0 to 35, where higher scores indicate worse urinary symptoms.
Time frame: From baseline to 10 years after randomization
International Index of Erectile Function-5 (IIEF-5)
Change from baseline in erectile function assessed using the International Index of Erectile Function-5 (IIEF-5). The IIEF-5 score ranges from 5 to 25, where higher scores indicate better erectile function.
Time frame: From baseline to 10 years after randomization
EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status
Change from baseline in global health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status scale. Scores range from 0 to 100, where higher scores indicate better global health status.
Time frame: From baseline to 10 years after randomization
EORTC Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25)
Change from baseline in prostate cancer-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25). Scores range from 0 to 100. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate worse symptoms.
Time frame: From baseline to 10 years after randomization
Patterns of First Disease Progression
Characterization of the first site and extent of disease progression, categorized as local (prostate), regional pelvic nodal, or distant metastatic progression, and classified as oligoprogressive or oligorecurrent disease (≤5 new or regrowing metastatic lesions) or polyprogressive or polymetastatic disease (\>5 lesions).
Time frame: Up to 10 years from randomization
Hazard Ratio for Metastasis-Free Survival per 10 Gy Increase in Delivered Prostate EQD2
Hazard ratio for metastasis-free survival associated with each 10 Gy increase in delivered prostate equivalent dose in 2 Gy fractions (EQD2, α/β = 1.5), estimated using Cox proportional hazards regression.
Time frame: Up to 10 years from randomization
Impact of OAR-Driven Nodal Dose De-Escalation
Assessment of the impact of protocol-defined organ-at-risk-driven nodal dose de-escalation on regional nodal control and treatment-related toxicity.
Time frame: Up to 10 years from randomization
Interaction Effect Between Radiotherapy Intensification and Systemic Therapy Intensification
Interaction term between radiotherapy intensification strategy (prostate-first vs combined prostate and nodal dose escalation) and systemic therapy intensification (androgen deprivation therapy with or without androgen receptor pathway inhibitors) evaluated in Cox proportional hazards models for metastasis-free survival. Reported as hazard ratio with interaction p-value.
Time frame: Up to 10 years from randomization
Hazard Ratio for Metastasis-Free Survival per 10 Gy Increase in Delivered Nodal EQD2
Hazard ratio for metastasis-free survival associated with each 10 Gy increase in delivered pelvic nodal EQD2 (α/β = 1.5), estimated using Cox proportional hazards regression.
Time frame: From randomization up to 10 years
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in primary and secondary publications will be shared. This includes baseline demographic and clinical characteristics, treatment allocation, radiotherapy and systemic treatment variables, outcome measures, and safety data necessary to reproduce the main analyses.
Supporting information: Study protocol, Statistical analysis plan
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.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2033, 92 months after the start.
Of 43 phase 2/3 interventional studies under Prostatic Neoplasms, half reached primary completion within 115 months of starting (the median), counting those still running; a quarter within 32. This study's planned 92 months is below that.
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