Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion

Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Targeted microwave ablation

Damien FONTANELLI, MSc

Alexandre PELTIER, MD

Franck BLADOU, MD

Aurel MESSAS, MD

Pierre MOZER, MD

Nicolas BARRY DELONGCHAMPS, MD

Eric POTIRON, MD

Bernard MALAVAUD, MD

Roland VAN VELTHOVEN, MD

Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.

European and American guidelines recommend several therapeutic alternatives: radical surgical treatment, external beam radiotherapy or brachytherapy. However, whole-gland treatment induces significant morbidity and burden on quality of life. Targeted treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.

The purpose of this study is to assess the efficacy of a novel ablation treatment using microwaves, delivered transrectally or transperineally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using Organ Based Tracking (OBT) fusion with the TRINITY system (KOELIS, Meylan, France). The same system will be used to identify the index lesion and guide the targeted microwave ablation performed with the TATO3 device (Biomedical Srl, Florence, Italy).

All patients will undergo biopsy at 12 months of follow-up. A biopsy session will also be performed at 6 months, but only for patients with imaging results suspicious for cancer within the ablated area on the mpMRI.

Multicenter, single-arm, open-label, 12-month follow-up clinical trial

Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

The proportion of patients with no evidence of cancer on targeted biopsy at 12 months, defined by a minimum of 2 targeted core biopsies taken from the index tumor site treated with microwave ablation for focal treatment of intermediate risk prostate cancer

Proportion of patients undergoing radical salvage treatment of the index lesion

Time to radical salvage treatment of the index lesion

Proportion of patients with any cancer in the untreated area, determined by a minimum 12 cores systematic biopsy

Proportion of patients undergoing treatment for cancer in the untreated area and time to treatment

Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS score compared to baseline, score ranging from 0 to 35 (the higher the worse)

Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF-5 score compared to baseline, score ranging from 5 to 25 (the lower the worse)

Changes in patients' reported outcome measures (PROMs) for ejaculatory function and bother using MSHQ-EjD-SF score compared to baseline, score ranging from 1 to 15 (the lower the worse) for ejaculatory function and from 0 to 5 for bother/satisfaction (the higher the worse)

Change in urine flow, using a uroflowmeter compared to baseline

Number and severity of device and procedure related adverse events

Average patient post-operative pain level reported on a pain numeric rating scale, with a range from 0 (no pain) to 10 (worst pain ever)

Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)

Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)

Duration of the procedure and associated variables

Change in PSA measurement compared to baseline

Time to PSA Nadir after treatment of the index lesion

Change in volume of the prostate on the mpMRI compared to baseline

Characterization of patient motivation to undergo targeted microwave ablation for treatment of the index lesion, as assessed by patient questionnaire (no score assigned)

Koelis

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Bone Diseases

Soft Tissue Sarcoma

Ewing Sarcoma

R1 - the experimental group. Standard oncological treatment will be started. Additionally, patients will receive regorafenib orally at doses adjusted for age, body surface area and pharmacokinetics. Treatment with regorafenib will be continued for up to 1 year or until disease progression, patient death, unacceptable toxicity, or study closure. Pharmacokinetics and safety profile of the investigational product (IP) will be determined throughout the course therapy.

R2 - the control group - will receive only standard treatment. In the event of progression or relapse, patients in the control group will have the option to receive the IP along with the standard treatment of the next line.

Patients will receive regorafenib orally at doses adjusted for age, body surface area and pharmacokinetics. Treatment with regorafenib will be continued for up to 1 year or until disease progression, patient death, unacceptable toxicity, or study closure. Pharmacokinetics and safety profile of the investigational product (IP) will be determined throughout the course therapy. In the event of progression or relapse, patients in the control group will have the option to receive the IP along with the standard treatment of the next line.

Regorafenib

Katarzyna Maleszewska

Katarzyna Maleszewska, mgr

Anna Raciborska, Prof.

DZIAŁ BADAŃ KLINICZNYCH

Piotr Rutkowski, Prof.

The aim of the project is to improve treatment outcomes in patients with primary malignant bone tumors, refractory to standard therapy, by increasing the availability of advanced therapy, as well as to develop treatment options using advanced molecular diagnostics for patients who have not responded to the standard therapeutic regimen, and to introduce modern diagnostics for risk stratification and for the use in molecularly targeted therapies.

The scope of the project is to cover the entire population of children, adolescents and young adults from the age of 9 to the age of 21, who progressed to first-line treatment or who presented with a recurrence of Ewing's sarcoma or osteosarcoma. Despite escalating doses of chemotherapy and radiotherapy, aggressive surgical procedures in patients with dissemination disease and negative prognostic factors, no improvement in treatment outcomes has been achieved for over 30 years. For this reason, other therapeutic options are being investigated. There have been no significant responses to immunotherapy. Although, the inclusion of tyrosine kinase inhibitors (TKIs) appears to be promising.

The identification of new mutations in bone tumors has led to a better insight into the molecular basis of these tumors, which has resulted in a more significant role of genetic research in everyday practice. Although traditional histopathological examinations are currently the basis for the diagnosis of bone tumors, the developing techniques of molecular biology make it possible, in many cases, to refine the diagnosis and, in the near future, will become the basis for the classification of these neoplasms. Moreover, these technics are expected to enable the qualification of patients to modern molecularly targeted therapies.

Based on the above data, the objectives of the project are as follows: 1. to estimate the nature and frequency of mutations in the tumor tissue, 2. to compare molecular test results with clinical data (which will allow for the initial assessment of the impact of the mutation status on the clinical condition, course of treatment and prognosis), 3. to include targeted treatment - broad spectrum tyrosine kinase inhibitor - regorafenib in standard therapy.

Regorafenib in Patients With Refractory Primary Bone Tumors

Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors

To explore the efficacy in terms of EFS - (Event-Free Survival)

Safety will be assessed by the rate of participants presenting with Adverse Events stratified by grade, category, affected organ or system, as number of serious adverse events (SAEs)

Safety will be assessed by the rate of participants presenting with Adverse Events stratified by grade, category, affected organ or system, as number of adverse events (AEs), including adverse events of special interest

Safety will be assessed by analyzing recorded vital signs, laboratory test results, echocardiography, and ECG.

progression-free survival - will be measured from randomization to the detection of disease progression in imaging tests.

overall survival - will be measured from randomization to death due to cancer.

the percentage of patients who achieved the response to treatment defined in the protocol.

Concentration parameters will come directly from the concentration values measured in PK samples.

by monitoring the patient's clinical and molecular status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer	NCT04582656	Prostate Cancer	Targeted microw...	45 Years - 76 Years	Koelis
Regorafenib in Patients With Refractory Primary Bone Tumors	NCT05395741	Osteosarcoma Ewing Sarcoma o...	Regorafenib	9 Years - 21 Years	Institute of Mother and Child, Warsaw, Poland

Spots Global Cancer Trial Database for targeted treatment