Metastatic Castration Resistant Prostate Cancer Clinical Trial
— OPTIMUMOfficial title:
Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker ‐ Drug Exposure ‐ as a Predictor for Drug Response in Patients With mCRPC
| NCT number | NCT02426333 |
| Other study ID # | UMCN AKF-14.07 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | August 1, 2019 |
| Verified date | September 2019 |
| Source | Radboud University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | August 1, 2019 |
| Est. primary completion date | April 24, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated - Age =18 years - Feasible to collect blood samples from - Life expectancy of > 6 months - Measurable disease - Able and willing to give written informed consent prior to screening and enrollment Exclusion Criteria: - other anticancer therapies - potent CYP3A4 inducers - herbal medicine that could interfere with abiraterone exposure |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
| Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
| Netherlands | Radboud UMC | Nijmegen |
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University | Janssen-Cilag Ltd. |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | abiraterone AUC | 6 months | ||
| Secondary | biomarkers: relation between biomarkers and treatment response | relation between biomarkers and treatment response | 6 months | |
| Secondary | biomarker reduction | To explore the if reduction in biomarkers is related to treatment response after three and six months | 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02495974 -
European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
||
| Completed |
NCT03641560 -
A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
|
Phase 4 | |
| Terminated |
NCT02441517 -
A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment
|
Phase 4 | |
| Active, not recruiting |
NCT03454750 -
Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)
|
Phase 2 | |
| Completed |
NCT03776968 -
A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT02471469 -
Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
|
||
| Terminated |
NCT03177187 -
Combination Study of AZD5069 and Enzalutamide.
|
Phase 1/Phase 2 | |
| Terminated |
NCT03531827 -
Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment
|
Phase 2 | |
| Completed |
NCT02566772 -
Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer
|
Phase 1 | |
| Completed |
NCT03829436 -
TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
|
Phase 1 | |
| Terminated |
NCT05241613 -
A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer
|
Phase 1 | |
| Recruiting |
NCT05369000 -
Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02975934 -
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
|
Phase 3 | |
| Active, not recruiting |
NCT04869488 -
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00428220 -
A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
|
N/A | |
| Completed |
NCT04056754 -
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
|
Phase 3 | |
| Completed |
NCT03658447 -
PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr)
|
Phase 1/Phase 2 | |
| Terminated |
NCT03042312 -
Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy
|
Phase 2 | |
| Completed |
NCT02991911 -
A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer
|
Phase 1 | |
| Completed |
NCT02655822 -
Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
|
Phase 1 |