Neoplasms

All Conditions

Heart and Blood Diseases

Rare Diseases

Glioma

Glioblastoma

Mitral Valve Insufficiency

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Functional MRI imaging and tomotherapy

Bassam Abdulkarim, MD

The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.

Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide

Cross Cancer Institute

AHS Cancer Control Alberta

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Hormones

Hormone Antagonists

2 tablets of 300 mg twice daily (=1200 mg/day) up to 5 years from randomisation

Darolutamide 300 mg

Over one week,30 Gy in 3 fractions of 10 Gy

Stereotactic body radiation therapy

Continuous ADT during the study course. The choice of ADT is left to the discretion of the investigator.

Androgen deprivation therapy

Ronan FLIPPOT

David PASQUIER

In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.

In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.

An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.

The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.

The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide.

PEACE 8 is a phase III open-label, randomised (patients are randomly assigned to treatment), international, multicentre trial, evaluating the benefit of adding SBRT to darolutamide for treating patients with oligometastatic CRPC.

Eligible patients will be randomised into either an experimental group receiving darolutamide + SBRT or a control group receiving darolutamide. In both arms, all patients will receive continuous castration (ADT) during the trial course.

Patients' participation in the trial will not exceed 60 months after randomisation, including a maximum treatment duration of 60 months and follow-up up to 60 months after randomisation.

After signing the consent form, patients will enter the pre-inclusion period (before the start of treatment), during which the investigator will carried out all the tests required to assess their eligibility, including demographic data collection, tumour evaluation, and clinical and biological assessments.

Patients will receive doralutamide until disease progression or unacceptable toxicity for a maximum of 5 years after the start of treatment.

To receive treatment, the patient will need to go to hospital, where, at each visit, the medical team will conduct medical examinations before administering the treatment to assess the patient's general state of health and tolerance to the treatment.

Eligible patients will be randomly allocated in a 1:1 ratio to either the:

* Control arm: ADT + darolutamide.
* Experimental arm: ADT + darolutamide + SBRT.

Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Combination of Darolutamide and Stereotactic Body Radiation Therapy in Patients With Castration Resistant Prostate Cancer and Oligometastases on Functional Imaging

The radiographic Progression-free survival is defined as the time interval between the randomisation and radiographic disease progression with conventional imaging (CT-scan or bone-scan), or death due to any cause, whichever occurs first.

The time to treatment failure is defined as the time interval between randomisation and the discontinuation of darolutamide, irrespective of the reason for discontinuation.

The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

The prostate cancer-specific survival is defined as the time interval between randomisation and the date of death due to prostate cancer.

The time to PSA progression is defined as the time interval between the date of randomisation and the date of PSA progression. PSA progression is defined, in accordance with the PCWG3 guidelines which retained the PCWG2 definition (2007 guidelines).

The biochemical response rate is defined as the proportion of patients with a decrease in PSA levels of ≥50% from baseline levels.

The time to next symptomatic skeletal event is defined as the time interval from randomisation until the first occurrence of a symptomatic fracture, bone radiation (for pain or neurological complication), bone surgery (for pain or neurological complication), or spinal cord compression.

The time to pain progression is defined as the time interval from randomisation until the first occurrence of any of the following:

* Increase of ≥2 points, from baseline, in question 3 of the Brief Pain Inventory-Short Form (BPI-SF) questionnaire (item related to the worst pain in the last 24 hours).
* Initiation of opioid treatment for cancer pain.
* Increase in the use of opioid treatment of ≥30% in terms of frequency of use or cumulative dose.

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

The FACT-P is a self-assessment questionnaire to estimate the health-related quality of life in men with prostate cancer. This questionnaire, composed of 39 items consists of four subscales: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), Functional Well-Being (7 items), and prostate cancer subscale (12 items). Subscales are rated on 5-point Likert-type scale (from 0 = "Not at all" to 4 = "Very much"). For all subscales, a higher score represents better quality of life.

The Brief Pain Inventory (BPI) questionnaire rapidly assesses the severity of pain and its impact on functioning. This self-report questionnaire includes:

* A body schema
* The maximum pain, lowest pain, usual pain within the last 15 days (Numeric rating scales (NRS) 0 to 10)
* Description of current analgesic treatment,
* An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 \[normal\] to 10 \[no activity\]).

Bayer

UNICANCER

Anti-Infective Agents

Nelfinavir

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

The start dose of nelfinavir in phase 1 is 1000mg BID. The maximum administered dose, if no DLT occurs, will be1250 mg BID (2500mg). Nelfinavir will be administered 1 week before start of the chemoradiotherapy until the last day of chemoradiotherapy.

nelfinavir

Brigitta Baumert, MD PhD

The objectives of the trial are:

To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma multiforme.

To describe the possible effect of nelfinavir on functional imaging To describe the activity of nelfinavir in vivo on blocking the AKT pathway.

Glioblastoma multiforme is the most malignant and common, about 50%, variant of all primary brain tumours. The treatment strategies for this disease have not changed appreciably for many years consisting of a surgical intervention (biopsy or tumour resection) and post-operative local radiotherapy until several years ago. Combined chemoradiotherapy with temozolomide is at the moment the standard medical practice after results of the joint EORTC-NCIC phase III study randomizing between radiotherapy alone and combined chemoradiotherapy with temozolomide showed a significant improvement in 2-years survival from 8% to 24% for the combined treatment arm (Stupp 2005). Given the poor prognosis of these patients and the still poor treatment response, further therapeutic improvement will remain the most challenging topic for the future. The next step to further improve survival for this patient group would be the addition of biological modifying and/or antiangiogenic therapies. These strategies are motivated by the fact that glioblastomas often express very high levels of vascular endothelial growth factor which is a key mediator of blood vessel growth as high expression of EGFR, which upregulates the downstream PI3K-AKTpathway. (Fischer I, Carmeliet P, Koul D) One possible candidate is nelfinavir, a protease inhibitor interfering with Akt activity downstream of EGFR and upstream of VEGF. (Geng L, Gorski D, HLu B)

Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma

Phase I/II Study for Patients With Newly Diagnosed Glioblastoma Testing Nelfinavir in Combination With Concomitant Temozolomide and Radiotherapy.

Maastricht University Medical Center

Maastricht Radiation Oncology

Head and Neck Neoplasms

Kate Newbold

Prased Dandekar

The purpose of the study is to generate a library of functional imaging and anatomical imaging for patients with head and neck cancers for evaluation of new radiotherapy strategies and planning techniques including IMRT. Secondary aims would be to observe the changes in the cancers as the treatment progresses as well as to define the biologically most active part of the tumor (biological target volume) which could be given more intensive treatment. Tumor volumes seen on different imaging modalities will be compared with a hope of finding an optimal imaging methodology for accurate visualization of the head and neck cancers

Adult patients who have a head and neck cancer and are planned to receive chemotherapy and radiotherapy will be invited to participate in the study. Patients who are not in very good health, have diabetes or kidney failure will not be considered for the study. Also patients who can not undergo MRI scan or are allergic to contrast injection given prior to the scan or have had any other form of cancer (except skin cancer) will also be excluded from the study.

Functional Imaging in HNC Undergoing Chemoradiation

Investigation of the Role of Functional Imaging in Characterising Radiotherapy Target Volumes and Assessing Disease Response in Patients Undergoing Chemoradiation for Head and Neck Cancer (HNC)

Royal Marsden NHS Foundation Trust

Dr Kate Newbold/ Chief Investigator

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm, Residual

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging.

MRD assessment includes liquid biopsy and functional imaging. Liquid biopsy will be performed by the Adaptive ClonoSEQ® assay in peripheral blood. Functional imaging will be performed by whole body diffusion-weighted magnetic resonance imaging (WB-DWI).

MRD Assessment

Research Nurse Navigator

Rajshekhar Chakraborty, MD

Chakraborty Chakraborty, MD

The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.

There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.

Non-invasive MRD Assessment in Multiple Myeloma

Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy

MRD assessment includes liquid biopsy and functional imaging.

Combining liquid biopsy, functional imaging, and bone marrow sampling against the reference of bone marrow sampling in patients

The progression-free survival (PFS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling)

The overall survival (OS) will be calculated of patients who are MRD-positive and MRD-negative on each modality (liquid biopsy, functional imaging, and bone marrow sampling)

Hope Foundation

Assistant Professor of Medicine

Magnetic Resonance Spectroscopy (3Tesla)

Matthew Parliament, MD

We seek to develop an advanced imaging approach to identifying and localizing prostate cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do this and we will endeavor to prove this by having patients with prostate cancer pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery, the microscopic locations of cancer will be compared with the pre-operative images to assess how well the imaging technique succeeds.

The proposed research is enormously relevant to the clinical understanding of early prostate cancer. We propose to test to see whether characteristic patterns of invivo 3T MRSI associated metabolites can be identified in correlation with clinically active tumor reserved on histopathologic analysis of resected specimens. We also plan to demonstrate that 3T MR spectra of prostate cancer will allow for more detailed metabolic assessment with higher sensitivity, specificity and accuracy and publish results established from MR spectra using 1.5T MR units. Functional imaging (eg. molecular imaging such as this) is felt to be the clinical wave of the future for cancer imaging, and if successful, will assume a very major role in the detection, assessment, treatment planning and delivery of drugs, radiation, heat and novel therapeutics in the fight against prostate cancer.

Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

Carcinoma

Body Weight

Patients will receive whole-body MRI with diffusion-weighted imaging at baseline and after 4 and 8 weeks of treatment.

MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation.

Whole-Body Diffusion Weighted MRI

Raquel Perez-Lopez, MD, PhD

Joan Carles, MD

Joaquin Mateo, MD, PhD

Rafael Morales, MD

Cristina Suarez, MD

Alonso Garcia, MD

The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment.

This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases.

The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.

Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer

A Study to Clinically Qualify Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) in Patients With Metastatic Castration Resistant Prostate Carcinoma With Bone Metastases

Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases

To use diffusion-weighted MRI for identifying anatomic regions of subclonal resistance to systemic treatment and study tumour evolution.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide	NCT00250211	Glioblastoma Glioma	Functional MRI ...	18 Years - 65 Years	AHS Cancer Control Alberta
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging	NCT06276465	Prostatic Cance...	Darolutamide 30... Stereotactic bo... Androgen depriv...	18 Years -	UNICANCER
Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma	NCT00694837	Glioblastoma	nelfinavir	18 Years - 65 Years	Maastricht Radiation Oncology
Functional Imaging in HNC Undergoing Chemoradiation	NCT00837980	Head and Neck C...		18 Years -	Royal Marsden NHS Foundation Trust
Non-invasive MRD Assessment in Multiple Myeloma	NCT05625971	Myeloma	MRD Assessment	18 Years -	Columbia University
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer	NCT00310479	Prostate Cancer	Magnetic Resona...	40 Years -	AHS Cancer Control Alberta
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer	NCT00310479	Prostate Cancer	Magnetic Resona...	40 Years -	AHS Cancer Control Alberta
Functional Imaging in HNC Undergoing Chemoradiation	NCT00837980	Head and Neck C...		18 Years -	Royal Marsden NHS Foundation Trust
Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide	NCT00250211	Glioblastoma Glioma	Functional MRI ...	18 Years - 65 Years	AHS Cancer Control Alberta
Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer	NCT05078151	Prostate Cancer...	Whole-Body Diff...	18 Years -	Vall d'Hebron Institute of Oncology

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