Prostatic Neoplasms, Castration-Resistant Clinical Trial
Official title:
Effect of a Reduced Dose on Cognitive Side Effects of Enzalutamide in Frail (Metastatic) Castration-resistant Prostate Cancer Patients (REDOSE)
Prostate cancer is the most commonly diagnosed cancer among men in Western countries. When the disease recurs as castration-resistant prostate cancer (CRPC) it is associated with a median overall survival of approximately 2 years with significant decrement in quality of life due to additional cancer-specific and treatment-induced morbidity. Palliative agents currently used in the CRPC setting include the 2nd generation hormonal agents abiraterone acetate and enzalutamide but also radium-223, docetaxel and cabazitaxel. Choices for treatment strategies are based on multiple factors such as age, co-morbidity and drug toxicity profile. The side effect profile of enzalutamide is associated with central nervous system (CNS side effects) such as fatigue and depression. The mechanism for these side effects is not yet fully understood, but it was shown in rodent studies that enzalutamide and its active metabolite penetrate into the CNS. This might cause the CNS side effects that were later seen in the phase 1 study where fatigue was found to be a dose-dependent adverse event. After dose reductions the symptoms resolved. This was also found in a retrospective study of Japanese metastatic CRPC (mCRPC) patients (n=345) in which the side effects malaise and nausea decreased remarkably after dose reduction. However, no exposure-response relation was observed in the study of Gibbons et al. Additionally, based on the data of the phase 1 trial of enzalutamide it can be suggested that a minimum trough concentration of 5.0 mg/L could be considered as a target for exposure to enzalutamide. In particular, frail (m)CRPC patients are more prone to develop CNS side effects on enzalutamide. The investigator's hypothesis is that dose reduction to 75% (120mg) can be safely done to treat (m)CRPC in these patients with preserving optimal efficacy and less CNS side effects.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04104776 -
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03325127 -
Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
|
||
| Withdrawn |
NCT02906605 -
A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05743621 -
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1 | |
| Completed |
NCT02204072 -
BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
|
Phase 1 | |
| Recruiting |
NCT05393791 -
Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
|
Phase 2 | |
| Completed |
NCT02450812 -
Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany
|
||
| Not yet recruiting |
NCT06353386 -
Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03431350 -
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03822845 -
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT02162836 -
A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1 | |
| Completed |
NCT02899104 -
Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
|
||
| Active, not recruiting |
NCT04381832 -
Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03563014 -
A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
|
||
| Active, not recruiting |
NCT05968599 -
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
|
||
| Active, not recruiting |
NCT02803437 -
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
|
||
| Recruiting |
NCT05944237 -
HTL0039732 in Participants With Advanced Solid Tumours
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03173859 -
Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
|
Phase 2 | |
| Terminated |
NCT02057666 -
Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04717154 -
Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer
|
Phase 2 |