A Phase 2/3 interventional study of Stereotactic Body Radiotherapy (SBRT) Monotherapy and External Beam Radiotherapy (EBRT) Backbone in Prostate Cancer (Adenocarcinoma), Prostate 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-LC is a prospective, multicenter, randomized phase II/III clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT).
Radiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PET imaging.
The aim of PRO-BOOST-LC is to compare definitive SBRT monotherapy with whole-gland prostate boost strategies delivered after a short course of external beam radiotherapy. Participants will be randomly assigned, according to center capability and patient-level technical suitability, to one of the protocol-defined treatment options. The control group receives SBRT monotherapy. The experimental groups receive external beam radiotherapy followed by one of three whole-gland boost techniques: HDR brachytherapy, LDR brachytherapy, or single-fraction SBRT boost.
The primary objective is to determine whether assignment to a prostate boost strategy improves failure-free survival compared with SBRT monotherapy. Failure-free survival includes biochemical recurrence, local or regional progression, distant metastases, progression-driven salvage treatment, or death from any cause. Key secondary outcomes include metastasis-free survival, overall survival, physician-reported treatment-related toxicity, and patient-reported quality of life, including urinary, bowel, and sexual function.
Participants will undergo baseline clinical evaluation, PSA testing, prostate MRI, PSMA PET/CT, and quality-of-life assessments. After treatment, participants will be followed regularly with clinical assessments, PSA testing, toxicity evaluation, patient questionnaires, and imaging when clinically indicated. The study is designed to provide long-term evidence on how best to use modern radiotherapy dose escalation for patients with PSMA-staged localized or locally advanced prostate cancer.
The PRO-BOOST-LC study is a prospective, multicenter, randomized phase II/III clinical trial designed to evaluate whether biologically intensified whole-gland prostate dose escalation improves clinically meaningful oncologic outcomes compared with contemporary stereotactic body radiotherapy (SBRT) monotherapy in patients with localized or locally advanced prostate cancer staged as cN0/cM0 on mandatory baseline prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT).
Scientific Background and Rationale Radiobiological and clinical evidence supports the concept that prostate cancer is sensitive to hypofractionation and dose escalation. Multiple randomized and prospective studies have shown that higher biologically effective radiation doses delivered to the prostate can improve biochemical control and delay disease progression. Modern dose-escalation techniques, including high-dose-rate (HDR) brachytherapy boost, low-dose-rate (LDR) brachytherapy boost, and stereotactic boost strategies, allow intraprostatic dose intensification while limiting dose to surrounding organs at risk.
Brachytherapy boost strategies enable delivery of very high biologically effective doses to the prostate. HDR boost offers optimized dose distribution and rapid dose fall-off, whereas LDR brachytherapy provides continuous low-dose radiation exposure over time through permanent seed implantation. SBRT boost is a non-invasive alternative capable of delivering a highly conformal ablative dose in a single fraction.
Although these approaches are used in clinical practice and have individually demonstrated favorable oncologic outcomes, direct prospective randomized comparison within a uniform treatment framework remains limited. In addition, many prior dose-escalation studies were conducted before the widespread use of PSMA PET/CT, which may have resulted in inclusion of patients with occult nodal or distant metastatic disease. PRO-BOOST-LC is designed to evaluate prostate dose-escalation strategies in a contemporary population staged with mandatory PSMA PET/CT.
Study Hypothesis The central hypothesis is that assignment to a whole-gland ablative boost strategy following a standardized ultrahypofractionated external beam radiotherapy backbone will improve failure-free survival compared with SBRT monotherapy, without an unacceptable increase in clinically significant toxicity or deterioration in patient-reported quality of life.
Overall Study Design PRO-BOOST-LC is a prospective, multicenter, randomized, controlled, multi-arm, multi-stage phase II/III trial with a seamless internal safety and feasibility stage.
Eligible patients are randomized using a centralized capability-based allocation procedure. The patient-level randomization set is determined before allocation according to center credentialing and technical suitability for the individual patient. The protocol-defined treatment strategies are:
SBRT monotherapy as the control strategy. Ultrahypofractionated external beam radiotherapy followed by HDR brachytherapy boost.
Ultrahypofractionated external beam radiotherapy followed by LDR brachytherapy boost.
Ultrahypofractionated external beam radiotherapy followed by single-fraction SBRT boost.
The primary comparison is pooled whole-gland boost strategy versus SBRT monotherapy. Comparisons among individual boost modalities are exploratory.
Seamless Phase II/III Structure The trial includes an internal phase II safety and feasibility component. During this stage, treatment delivery compliance, acute toxicity, technical feasibility, and major radiotherapy protocol deviations are prospectively monitored. Predefined safety and feasibility thresholds are reviewed by the Data Safety Monitoring Board. An experimental treatment arm may be continued, modified, temporarily suspended, or discontinued based on safety, feasibility, or protocol-compliance findings. Arms meeting predefined criteria proceed into the confirmatory phase III stage without interruption of accrual.
Treatment Principles All treatments are delivered with curative intent using contemporary image-guided radiotherapy techniques. Multiparametric MRI-based planning is mandatory for all patients. Baseline PSMA PET/CT is mandatory for staging confirmation of node-negative and non-metastatic disease.
The ultrahypofractionated external beam radiotherapy backbone consists of five high-dose fractions delivered using intensity-modulated radiotherapy or volumetric modulated arc therapy with daily image guidance. This backbone serves as a standardized platform across experimental boost arms.
Whole-gland boost delivery differs by modality. HDR brachytherapy boost consists of a single high-dose fraction delivered through temporary transperineal catheter implantation under image guidance. LDR brachytherapy boost consists of permanent seed implantation. SBRT boost consists of a single ablative stereotactic fraction delivered with dedicated immobilization and high-precision image guidance. The control arm consists of SBRT monotherapy delivered in five fractions.
Androgen deprivation therapy is administered according to contemporary guideline-based risk stratification. Protocol-planned androgen receptor pathway inhibitors may be used in selected very high-risk or locally advanced patients when declared before randomization and handled according to the protocol and statistical analysis plan.
Imaging Integration Baseline staging requires PSMA PET/CT and multiparametric MRI within protocol-defined timeframes before randomization. Imaging is used to confirm cN0/cM0 status and to support radiotherapy planning.
Follow-up imaging is performed when clinically indicated. PSMA PET/CT is prioritized for evaluation of suspected recurrence or distant metastatic progression. Local recurrence requires radiologic progression confirmation and is not defined solely by PSA kinetics or isolated biopsy findings.
Endpoint Strategy
The primary endpoint is failure-free survival (FFS). Failure-free survival includes biochemical recurrence, radiologically documented local, regional, or distant progression, progression-driven salvage treatment, or death from any cause.
Metastasis-free survival (MFS) is a key hierarchical confirmatory endpoint and is tested only if the primary failure-free survival comparison is statistically significant. Secondary and exploratory analyses evaluate local and regional control, treatment-related toxicity, patient-reported quality of life, PSA kinetics, time to salvage therapy, cancer-specific survival, and overall survival.
Patient-Reported Outcomes Patient-reported outcomes are a core component of the study. Validated questionnaires are used to assess urinary, bowel, sexual, hormonal, and general health-related quality of life domains at baseline and during follow-up. These assessments are intended to determine whether improved oncologic control can be achieved while preserving long-term function and quality of life.
Toxicity Monitoring Adverse events are graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Acute toxicity is defined as adverse events occurring within 90 days after completion of protocol radiotherapy. Late toxicity includes adverse events occurring beyond 90 days.
Genitourinary, gastrointestinal, sexual, systemic therapy-related, and procedure-related adverse events are recorded prospectively. For clinically significant events, the maximum grade, attribution, onset date, resolution or improvement date, ongoing status, and relationship to treatment components are documented. Safety data are reviewed periodically by the Data Safety Monitoring Board.
Statistical Considerations The study is powered for the primary comparison of pooled whole-gland boost strategies versus SBRT monotherapy for failure-free survival. Time-to-event analyses will use prespecified statistical methods including Kaplan-Meier estimation and Cox proportional hazards modeling. The hierarchical endpoint strategy is designed to preserve the overall type I error rate.
Clinical Significance By integrating PSMA PET/CT staging, contemporary ultrahypofractionated radiotherapy, brachytherapy boost, SBRT boost, standardized radiotherapy quality assurance, toxicity monitoring, and patient-reported outcomes, PRO-BOOST-LC aims to generate high-quality evidence on how best to use prostate dose escalation in localized and locally advanced prostate cancer.
The study is intended to clarify which modern radiotherapy dose-escalation strategy provides the most favorable balance between durable cancer control, treatment-related toxicity, and long-term preservation of urinary, bowel, sexual, and overall quality of life.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 1,000 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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned to this arm receive definitive stereotactic body radiotherapy (SBRT) delivered to the prostate as monotherapy, without any additional intraprostatic boost. Treatment is administered using an ultrahypofractionated regimen with highly conformal dose delivery, daily image guidance, and motion management according to protocol-defined standards. Target volumes and organs at risk are contoured following centralized guidelines, and treatment planning adheres to predefined coverage objectives and dose constraints. This arm represents a contemporary, non-invasive definitive radiotherapy strategy for localized prostate cancer and serves as the active comparator for all boost-based dose escalation approaches evaluated in the study. Androgen deprivation therapy may be administered according to protocol-defined risk group and current clinical practice guidelines.
Radiation: Stereotactic Body Radiotherapy (SBRT) Monotherapy · Drug: Androgen Deprivation Therapy (ADT)
Patients assigned to this arm receive a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone delivered to the prostate using modern image-guided techniques, followed by an intraprostatic boost delivered with high-dose-rate (HDR) brachytherapy. The EBRT component provides uniform baseline irradiation, after which a single-fraction HDR brachytherapy boost is administered using transperineal catheter placement and afterloading according to protocol-defined technical and dosimetric criteria. This approach enables delivery of a very high biologically effective dose to the prostate while maintaining strict organ-at-risk constraints. Target coverage objectives, applicator placement principles, and dose limits are standardized across centers. Androgen deprivation therapy may be administered according to protocol-defined risk group and standard clinical practice.
Radiation: External Beam Radiotherapy (EBRT) Backbone · Radiation: High-Dose-Rate Brachytherapy Boost · Drug: Androgen Deprivation Therapy (ADT)
Patients assigned to this arm receive a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone delivered to the prostate, followed by an intraprostatic boost using low-dose-rate (LDR) permanent seed brachytherapy. After completion of EBRT, LDR brachytherapy is performed with transperineal implantation of radioactive seeds according to protocol-defined planning, implantation, and post-implant dosimetric criteria. This strategy achieves dose escalation through continuous low-dose-rate irradiation while respecting predefined target coverage goals and organ-at-risk constraints. Implant quality and dosimetry are centrally specified to ensure consistency across participating centers. Androgen deprivation therapy may be administered based on protocol-defined risk group and standard clinical practice.
Radiation: External Beam Radiotherapy (EBRT) Backbone · Radiation: Low-Dose-Rate Brachytherapy Boost · Drug: Androgen Deprivation Therapy (ADT)
Patients assigned to this arm receive a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone delivered to the prostate, followed by an intraprostatic stereotactic body radiotherapy (SBRT) boost. The EBRT component establishes baseline target coverage, after which a highly conformal SBRT boost is delivered in a single fraction using advanced image guidance and motion management. This arm represents a fully non-invasive dose escalation strategy that avoids brachytherapy while enabling delivery of a high biologically effective intraprostatic dose. Treatment planning and delivery follow protocol-defined target coverage objectives and organ-at-risk constraints to ensure safety and consistency. Androgen deprivation therapy may be administered according to protocol-defined criteria.
Radiation: External Beam Radiotherapy (EBRT) Backbone · Radiation: Stereotactic Body Radiotherapy (SBRT) Boost · Drug: Androgen Deprivation Therapy (ADT)
Stereotactic body radiotherapy (SBRT) delivered to the prostate as definitive monotherapy using an ultrahypofractionated schedule. Treatment is planned with highly conformal techniques and daily image guidance according to protocol-defined target coverage objectives and organ-at-risk constraints. This intervention represents a non-invasive definitive radiotherapy strategy without additional intraprostatic boost.
Ultrahypofractionated external beam radiotherapy delivered to the prostate using volumetric modulated arc therapy (VMAT) or equivalent intensity-modulated techniques. This intervention serves as a standardized treatment backbone prior to intraprostatic dose escalation and is delivered according to protocol-defined target volumes, margins, and dose constraints.
Intraprostatic high-dose-rate brachytherapy delivered as a single-fraction boost following completion of external beam radiotherapy. The procedure involves transperineal catheter placement with afterloading and is performed according to protocol-defined technical, dosimetric, and safety criteria to achieve focal dose escalation while respecting organ-at-risk constraints.
Intraprostatic low-dose-rate permanent seed brachytherapy delivered as a boost following completion of external beam radiotherapy. Radioactive seeds are implanted transperineally according to protocol-defined planning and implantation guidelines to provide continuous low-dose-rate irradiation while maintaining predefined target coverage and organ-at-risk constraints.
Intraprostatic stereotactic body radiotherapy delivered as a single-fraction boost following completion of external beam radiotherapy. This intervention provides non-invasive dose escalation using highly conformal planning and image guidance according to protocol-defined coverage objectives and organ-at-risk constraints.
Androgen deprivation therapy (ADT) administered according to protocol-defined risk group and standard clinical practice. ADT may include luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, with or without short-course antiandrogens, delivered as neoadjuvant, concurrent, and/or adjuvant therapy in accordance with contemporary clinical guidelines. ADT is not randomized and is applied uniformly within each risk group across all treatment arms.
Failure-Free Survival (FFS)
Failure-Free Survival (FFS) is defined as the time from randomization to the earliest occurrence of any of the following events: biochemical recurrence according to the Phoenix definition (PSA nadir + 2 ng/mL), confirmed local recurrence within the prostate, regional pelvic nodal progression, distant metastatic disease, initiation of salvage therapy, or death from any cause. Local recurrence is defined by radiologic progression on multiparametric MRI or PSMA PET/CT confirmed on repeat imaging ≥6 months later, or biopsy-proven viable adenocarcinoma in the presence of radiologic progression. Regional nodal progression includes pelvic nodal relapse (obturator, internal iliac, external iliac, presacral nodes). Patients without an event will be censored at the date of last disease assessment.
Time frame: From randomization up to 10 years
Metastasis-Free Survival (MFS) hierarchical
Metastasis-Free Survival (MFS) is defined as the time from randomization to the occurrence of distant metastatic disease or death from any cause, whichever occurs first. Distant metastases are defined as non-pelvic nodal disease (including common iliac nodes) or visceral or bone metastases detected preferentially by PSMA PET/CT and confirmed according to protocol-defined imaging criteria. MFS is analyzed as a key confirmatory endpoint within a hierarchical testing strategy and will be formally tested only if the primary comparison for Failure-Free Survival is statistically significant. MFS is assessed in accordance with EAU/ASTRO/STRATOS consensus definitions and is recognized as a validated surrogate for overall survival in localized and locally advanced prostate cancer.
Time frame: From randomization up to 10 years
Intraprostatic Local Control (iLC)
Intraprostatic local control is defined as the time from randomization to confirmed local recurrence within the prostate gland. Local recurrence is determined by radiologic progression on multiparametric MRI or PSMA PET/CT confirmed on repeat imaging performed at least 6 months later, or by biopsy-proven viable adenocarcinoma in the presence of radiologic progression. This endpoint evaluates the effectiveness of intraprostatic dose escalation strategies.
Time frame: From randomization up to 10 years
Regional Pelvic Nodal Control (rNC)
Regional pelvic nodal control is defined as the time from randomization to pelvic nodal progression detected on imaging. Pelvic nodal progression includes involvement of obturator, internal iliac, external iliac, or presacral lymph nodes. Progression in common iliac lymph nodes is classified as distant metastatic disease and is not considered a regional nodal event. Nodal progression must be confirmed on imaging according to protocol-defined criteria.
Time frame: From randomization up to 10 years
Acute Genitourinary and Gastrointestinal Toxicity
Acute genitourinary (GU) and gastrointestinal (GI) toxicity is defined as treatment-related adverse events occurring within 90 days from completion of radiotherapy. Toxicity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. The incidence and severity of acute adverse events will be systematically recorded at scheduled follow-up visits.
Time frame: From start of radiotherapy to 90 days after completion
Late Genitourinary and Gastrointestinal Toxicity
Late genitourinary (GU) and gastrointestinal (GI) toxicity is defined as treatment-related adverse events occurring more than 90 days after completion of radiotherapy. Toxicity will be graded using CTCAE version 6.0. This endpoint assesses long-term safety and tolerability of dose-escalated and boost-based radiotherapy strategies.
Time frame: More than 90 days after completion of radiotherapy up to 10 years
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Change from baseline in Expanded Prostate Cancer Index Composite-26 (EPIC-26) domain scores. EPIC-26 assesses urinary, bowel, sexual, and hormonal domains. Each domain score ranges from 0 to 100. Higher scores indicate better quality of life (fewer symptoms and better function).
Time frame: From baseline up to 10 years
EORTC QLQ-C30 Global Health Status Score
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status score. Scores range from 0 to 100. Higher scores indicate better global health-related quality of life.
Time frame: From baseline up to 10 years
PSA Nadir
Lowest prostate-specific antigen value recorded after completion of radiotherapy. Measured in ng/mL. Lower values indicate better biochemical response.
Time frame: From randomization up to 10 years
Time to Initiation of Salvage Therapy
Time from randomization to initiation of salvage treatment, including re-initiation of androgen deprivation therapy, initiation of androgen receptor pathway inhibitors, local salvage therapies, or systemic therapy for metastatic disease.
Time frame: From randomization up to 10 years
Cancer-Specific Survival (CSS)
Time from randomization to death attributable to prostate cancer.
Time frame: From randomization up to 10 years
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: From randomization up to 10 years
International Prostate Symptom Score (IPSS)
Change from baseline in International Prostate Symptom Score (IPSS). IPSS ranges from 0 to 35. Higher scores indicate worse urinary symptoms.
Time frame: Time Frame: From baseline up to 10 years
EORTC QLQ-PR25 Prostate Cancer Module
Change from baseline in European Organisation for Research and Treatment of Cancer Prostate Cancer Module (EORTC QLQ-PR25) domain scores. 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 up to 10 years
Time to PSA Nadir
Time from completion of radiotherapy to lowest PSA value. Measured in months.
Time frame: Up to 10 years
PSA Doubling Time
PSA doubling time calculated using at least three consecutive PSA values after nadir. Measured in months. Shorter doubling time indicates more aggressive disease.
Time frame: Up to 10 years
PSA Bounce
Incidence of PSA bounce defined as a rise ≥0.2 ng/mL above nadir followed by spontaneous decline without intervention. Measured as proportion of patients experiencing bounce.
Time frame: Up to 10 years
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in publications arising from this study will be made available upon reasonable request. Shared data will include baseline characteristics, treatment allocation, dosimetric parameters, outcome variables, and follow-up data necessary to reproduce the primary and secondary analyses. Data will be shared in accordance with applicable data protection regulations and only after approval of a methodologically sound research proposal.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD and supporting documentation will become available beginning 6 months after publication of the primary results and will remain available for a minimum of 5 years following publication.
Access criteria: Access to de-identified IPD will be granted to qualified researchers who submit a written request describing the research question, analysis plan, and intended use of the data. Requests will be reviewed by the study steering committee to ensure scientific merit, feasibility, and compliance with ethical and data protection requirements. Approved users will be required to sign a data use agreement prior to data release.
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