Publications by authors named "Bertrand Tombal"

Background: Meaningful patient engagement (PE) is increasingly recognized as a critical element of clinical cancer research. Policy frameworks in Europe and Japan reflect growing support for involving patients in research and policymaking. However, tools to assess the actual implementation of PE in clinical trials remain limited.

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Background And Objective: Lymph node-positive (pN1) prostate cancer (PCa) is a heterogeneous disease, and a clear definition of prognostic groups is urgently needed. We aimed to assess cancer-related mortality (CRM) in different prognostic groups of pN1 patients, created based on the pathological PCa characteristics and number of positive lymph nodes (LN+).

Methods: We conducted a retrospective, multicentre cohort study including 894 patients with pN1 disease treated at 15 European high-volume centres.

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Background And Objective: This narrative review explores the impact of carcinoma in situ (CIS) on outcomes in muscle-invasive bladder cancer (MIBC) after trimodal therapy (TMT) comprising transurethral resection of bladder tumor, a radiosensitizing agent and radiation therapy (RT). There is limited and inconsistent evidence on the effect of CIS, often considered a contraindication to TMT, on treatment efficacy.

Methods: We reviewed studies evaluating the influence of TMT and RT alone on clinical outcomes in CIS-associated MIBC.

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Background And Objective: Darolutamide + docetaxel + androgen-deprivation therapy (ADT) significantly improved overall survival (OS) and delayed time to disease progression versus docetaxel + ADT in ARASENS (NCT02799602). We report data on subsequent antineoplastic therapies received and associated OS after discontinuation of the study treatment.

Methods: Patients were randomized 1:1 to darolutamide 600 mg orally twice daily or placebo, both with docetaxel + ADT.

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The standard of care (SOC) for treatment of muscle-invasive bladder cancer is neoadjuvant systemic treatment (NAT) with chemotherapy ± immunotherapy (pending durvalumab approval for this indication) followed by cystectomy or radiochemotherapy, regardless of the extent of any tumor response. Studies have recently begun to question the pertinence of local treatment in cases with a complete clinical response after NAT. However, such a de-escalation strategy is hampered by the poor correlation between clinical evaluation of the tumor response and final pathology results for radical cystectomy specimens.

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Purpose: Next-generation imaging techniques, including PSMA-PET/CT and whole-body MRI (WB-MRI), are disrupting the management of prostate cancer (PCa). This study aimed to build a fast "All-In-One" WB-MRI protocol and to compare it to Ga-PSMA-PET/CT for local (T), nodal (N), and distant staging (M1a, M1b, M1c).

Methods: Fifty-two PCa patients at high-risk for metastases underwent a fast "All-in-One" WB-MRI (combining biparametric prostate assessment based on rapid T2-weighted and diffusion-weighted imaging (DWI) following the PI-RADS v2.

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Background And Objective: The treatment landscape for advanced prostate cancer has evolved significantly over the past decade. The introduction of docetaxel, androgen receptor pathway inhibitors (ARPIs), poly(ADP-ribose) polymerase inhibitors, and targeted radionuclides has redefined the treatment paradigm, with a focus now on early treatment intensification through combination therapies. This narrative collaborative review summarises the current evidence of combination therapies in locally advanced and metastatic hormone-sensitive prostate cancer (mHSPC).

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Aim: Addition of abiraterone acetate plus prednisone (AAP) to androgen deprivation therapy (ADT) with or without docetaxel (D) improved overall survival in patients with de novo metastatic castration sensitive prostate cancer in the PEACE-1 trial. The protocol was amended during the course of the study to assess whether addition of AAP increases bone loss.

Methods: Patients were randomized to receive either ADT + D with or without AAP.

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Introduction: Vasectomy is a widely used, safe, effective method of permanent contraception and contributes to healthy sexuality.

Aims: We have conducted a 3-step observational clinical study to develop a vasectomy regret risk score and guide patients and clinicians when discussing a vasectomy.

Methods: A 3-step approach has been followed.

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Bone health is central to the management of patients with metastatic castration-resistant prostate cancer (mCRPC). International guidelines recommend giving a bone-protecting agent (BPA) to patients with mCRPC and bone metastases. However, the data supporting these recommendations were generated before androgen receptor pathway inhibitors (ARPIs) were available.

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Background: Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (Ra) treatment, but their association with treatment outcomes is unclear.

Methods: For patients with metastatic castration-resistant prostate cancer treated with Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2).

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Article Synopsis
  • The study analyzes how clinical risk stratification can be used to assess the advantages of long-term androgen deprivation therapy (ltADT) compared to short-term therapy (stADT) in high-risk localized prostate cancer patients.
  • Results indicate that patients with very-high risk features have greater improvements in survival outcomes when treated with ltADT, although the variation in treatment effects across different risk groups is not statistically significant.
  • The findings suggest the need for further clinical trials to refine risk stratification methods and better identify which high-risk localized prostate cancer patients could benefit more from longer therapy.
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Background: The 2 × 2 PEACE-1 study showed that combining androgen-deprivation therapy with docetaxel and abiraterone improved overall and radiographic progression-free survival in patients with de novo metastatic castration-sensitive prostate cancer. We aimed to examine the efficacy and safety of adding radiotherapy in this population.

Methods: We conducted an open-label, randomised, controlled, phase 3 trial with a 2 × 2 factorial design (PEACE-1) at 77 hospitals across Europe.

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The penis is a relatively uncommon organ for metastases. Secondary lesions often originate from the bladder, prostate, or rectosigmoid cancers. Only a few cases have described penile lesions secondary to lung cancers, mostly as a later complication.

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Several life-prolonging therapies with diverse mechanisms of action (MoA) are available for the treatment of metastatic hormone-sensitive/castration-resistant prostate cancer, with many patients requiring multiple lines of therapy. Nevertheless, treatment optimization to further delay disease progression and improve overall survival remains an unmet need. Despite the number of agents with differing MoAs approved for advanced prostate cancer, many patients receive only one or two life-prolonging therapies.

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Article Synopsis
  • Darolutamide combined with androgen-deprivation therapy (ADT) and docetaxel significantly lowered the risk of death by 32.5% in the ARASENS study, indicating its effectiveness for treating metastatic hormone-sensitive prostate cancer (mHSPC).
  • In the Japanese subgroup analysis of 148 patients, higher percentages of participants were older (≥75 years) and had lower body mass indexes compared to the overall study population, but the treatment showed a similar safety and efficacy profile.
  • While overall survival trends were positive for darolutamide in Japanese patients, the combined treatment was well tolerated, with no new safety concerns identified, despite some patients experiencing more frequent adverse events like neutropenia.
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Background And Objectives: We assessed the agreement between prostate-specific antigen (PSA) and imaging responses using whole-body magnetic resonance imaging (wbMRI). Our aim was to explore the potential prognostic value of PSA and wbMRI responses in metastatic hormone-naïve prostate cancer (mHNPC) and castration-resistant PC (mCRPC).

Methods: wbMRI was prospectively performed in 37 patients with mHNPC and 51 with mCRPC before and after 6-12 mo of androgen deprivation therapy and an androgen receptor pathway inhibitor (ARPI).

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Article Synopsis
  • Innovations in advanced prostate cancer have improved outcomes, but there's still a lack of high-level evidence in clinical management, prompting the 2024 Advanced Prostate Cancer Consensus Conference to survey experts for insights.
  • A panel of 120 international experts developed and voted on 183 consensus questions through a web-based survey prior to the conference, defining consensus as ≥75% agreement.
  • The voting results highlight areas of agreement and disagreement that can guide clinical decisions and future research, with a focus on individualizing treatment based on patient characteristics and encouraging participation in clinical trials.
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Article Synopsis
  • Recent research has led to the approval of three new therapy combinations for treating metastatic castration-resistant prostate cancer (mCRPC), emphasizing the need to explore treatment intensification strategies.
  • A systematic review was conducted, adhering to PRISMA-P guidelines, which included data from multiple databases and outlined optimal treatment sequencing using androgen receptor inhibitors and other therapies.
  • The findings demonstrated that certain drug combinations, particularly involving ARPI and other selective agents, significantly improve progression-free survival for specific patient groups, highlighting an evolving treatment landscape in mCRPC.
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Article Synopsis
  • Early salvage radiotherapy (SRT) is a treatment for patients who have issues after prostate surgery, but results can vary a lot.
  • Researchers wanted to create a scoring system to help predict how well patients would do with SRT based on certain risk factors.
  • The study found that three major factors—PSA levels, Gleason Score, and margin status—can help doctors give better advice to patients about their treatment options.
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Enhancement of the participant experience in quality of life (QOL) research is imperative to improve recruitment and ongoing engagement in QOL studies. Implementation of recommendations made by the patient and public involvement representatives for STAMPEDE2 could optimise the impact of QOL studies, with a benefit for participants and collection of invaluable data for cancer care research.

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Article Synopsis
  • Advanced metastatic prostate cancer is a complex disease primarily treated with a combination of androgen deprivation therapy and androgen receptor pathway inhibitors (ARPI).
  • After ARPI treatment, various therapies can be administered in sequence, but it’s crucial to choose the right patients for these treatments.
  • There is a pressing need to discover clinical or molecular factors that can help in making informed decisions about treatment sequences for patients.
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