Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

All Drugs and Chemicals

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

Immune System Diseases

Hypersensitivity

Antineoplastic Agents

Anti-Inflammatory Agents

Reproductive Control Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Docetaxel

Abiraterone Acetate

Prednisone

Prednisolone

Leuprolide

Relugolix

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Antineoplastic Agents, Hormonal

Protective Agents

Androgen Antagonists

Participants will receive relugolix in combination with abiraterone plus a corticosteroid for 12 weeks during the study treatment period.

Participants will receive relugolix in combination with apalutamide for 12 weeks during the study treatment period.

Participants will receive relugolix in combination with docetaxel with or without prednisone for 12 weeks during the study treatment period.

(Part 1 and Part 3) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 120-mg dose (1 x 120-mg tablets), taken once daily at approximately the same time each day.

(Part 2) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 240-mg dose (2 x 120-mg tablets), taken once daily at approximately the same time each day.

Abiraterone acetate (1000 mg \[2 x 500-mg tablets\]) or fine-particle abiraterone acetate (500 mg \[4 x 125-mg tablets\]) will be administered orally once daily.

Abiraterone

(Part 1 only) For participants with mCSPC, a 5-mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5-mg dose of prednisone will be administered orally twice daily.

(Part 3 only) Prednisone 5 mg can be administered orally twice daily but is not required.

For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.

Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.

Apalutamide

Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.

Mike Ufer

This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).

This is a three-part, open-label, parallel-cohort study to assess the safety and tolerability of relugolix as the ADT component in combination treatment with abiraterone acetate plus a corticosteroid in patients with mCSPC or mCRPC (Part 1), apalutamide in patients with mCSPC or nmCRPC (Part 2), or docetaxel with or without prednisone in patients with mCSPC or mCRPC (Part 3).

The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments (Parts 1, 2, or 3). All participants are required to be currently or previously treated with a GnRH receptor antagonist (analog), leuprolide acetate or triptorelin, or a GnRH receptor antagonist, degarelix or relugolix, in combination with either abiraterone plus prednisone (Part 1), apalutamide (Part 2), or docetaxel (Part 3). The study consists of a 12-week primary study treatment period in which safety and tolerability, including assessment of vital sign measurements, ECGs, clinical laboratory tests and reporting of adverse events every 2 to 4 weeks, followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported. The total treatment duration is 52 weeks.

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Sumitomo Pharma Switzerland GmbH

Rare Diseases

Kennedy Disease

Androgen Receptor Antagonists

Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Darolutamide as initial treatment.

Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Enzalutamide as initial treatment.

Participants with nmPC previously untreated with novel ARIs or abiraterone acetate and received Apalutamide as initial treatment.

Retrospective cohort analysis, using Komodo Research Database (KRD)

Darolutamide (Nubeqa, BAY1841788)

Enzalutamide

This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.

Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body.

Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information.

Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones.

The main purpose of this study is to collect and study information from men with nmPC about:

* the length of time they continued treatment with an ARI as prescribed by their doctors.
* the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body.

Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US.

The data collected will be from May 2019 to June 2023.

Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

ARI Treatment Use and Outcomes in Non-metastatic Prostate Cancer (nmPC) Patients in the US

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

PDC is calculated by dividing the total non-overlapping days of supply by the length of a fixed time interval (6, 12, 18, 24 months) and by the patient specific treatment duration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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 of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer	NCT04666129	Metastatic Cast... Metastatic Cast... Non-Metastatic ...	Relugolix Abiraterone Prednisone Methylprednisol... Apalutamide Docetaxel	18 Years -	Sumitomo Pharma Switzerland GmbH
An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States	NCT06204302	Non-metastatic ... Non-metastatic ...	Darolutamide (N... Enzalutamide Apalutamide	18 Years -	Bayer
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer	NCT04666129	Metastatic Cast... Metastatic Cast... Non-Metastatic ...	Relugolix Abiraterone Prednisone Methylprednisol... Apalutamide Docetaxel	18 Years -	Sumitomo Pharma Switzerland GmbH

Spots Global Cancer Trial Database for nmcrpc

Every month we try and update this database with for nmcrpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nmcrpc

Every month we try and update this database with for nmcrpc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nmcrpc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.