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Report for D011471: Prostatic Neoplasms NIH
(Synonyms: Prostatic N, Prostatic Ne, Prostatic Neo, Prostatic Neop, Prostatic Neopl, Prostatic Neopla, Prostatic Neoplas, Prostatic Neoplasm, Prostatic Neoplasms)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (21)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1131 | Hydroxychloroquine, Doxycycline Wiki | 0.58 |
| drug2520 | Tildrakizumab Wiki | 0.58 |
| drug104 | Abiraterone Acetate Wiki | 0.58 |
| drug2810 | enzalutamide Placebo Wiki | 0.58 |
| drug782 | Docetaxel Wiki | 0.58 |
| drug2991 | rosuvastatin Wiki | 0.58 |
| drug1223 | Interferon-Alpha2B Wiki | 0.58 |
| drug1130 | Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki | 0.58 |
| drug1127 | Hydroxychloroquine, Azithromycin Wiki | 0.58 |
| drug330 | Berzosertib Wiki | 0.58 |
| drug2804 | digoxin Wiki | 0.58 |
| drug656 | Convalescent Serum Wiki | 0.58 |
| drug1129 | Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki | 0.58 |
| drug1319 | Laboratory Biomarker Analysis Wiki | 0.58 |
| drug1128 | Hydroxychloroquine, Clindamycin Wiki | 0.58 |
| drug2809 | enzalutamide Wiki | 0.58 |
| drug522 | Carboplatin Wiki | 0.41 |
| drug1374 | Losartan Wiki | 0.20 |
| drug1484 | Methylprednisolone Wiki | 0.17 |
| drug2067 | Remdesivir Wiki | 0.15 |
| drug2527 | Tocilizumab Wiki | 0.11 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012125 | Prostate cancer HPO | 1.00 |
| HP:0030731 | Carcinoma HPO | 0.26 |
There are 3 clinical trials
Clinical Trials
1 A Phase 2 Study of M6620 in Combination With Carboplatin Compared With Docetaxel in Combination With Carboplatin in Metastatic Castration-Resistant Prostate Cancer
This phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.
NCT03517969 Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Drug: Berzosertib Drug: Carboplatin Drug: Docetaxel Other: Laboratory Biomarker Analysis MeSH:Carcinoma Prostatic Neoplasms
HPO:Carcinoma Prostate cancer Prostate neoplasm
Primary Outcomes
Description: Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen [PSA] response of > 50%). Will be conducted using the Cochran-Mantel-Haenszel test, with one-sided p-value of =< 0.05 considered significant.
Measure: Response rate (complete response + partial response) Time: Up to 2 years
Secondary Outcomes
Description: Assessed by Prostate Cancer Working Group (PCWG)3. PFS to be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Progression-free survival (PFS) Time: From the time of randomization up to 2 years
Description: Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval. Comparison of time to PSA progression between arms will be conducted using the log-rank test.
Measure: Time to PSA progression Time: From the time of randomization up to 2 years
Description: Assessed by RECIST 1.1. rPFS will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Radiographic progression-free survival (rPFS) Time: From the time of randomization up to 2 years
Description: Will be summarized according to treatment arm. For toxicity reporting, all adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Type of adverse events, intensity (grading), and attribution will be provided in a listing. All adverse events resulting in discontinuation, dose modification, and/or dosing interruption, and/or treatment delay of drug will also be summarized. Laboratory test results will be classified according to the CTCAE version 5.0.
Measure: Incidence of adverse events Time: Up to 2 years
Other Outcomes
Description: OS will be estimated with the Kaplan Meier methodology. Comparison of OS between arms will be conducted using the log-rank test base on the intention-to-treat approach, where two treatment arms will be compared regardless of cross-over or any subsequent therapy.
Measure: Overall survival (OS) Time: From the time of randomization up to 2 years
Description: Gene mutation frequencies and mean +/- standard deviation of quantitative biomarkers will be summarized by arm and in overall population at baseline and/or at end of study.
Measure: Gene mutation frequencies Time: Baseline up to 2 years
2 A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates of P-glycoprotein (Digoxin) and Breast Cancer Resistant Protein (Rosuvastatin) in Male Subjects With Prostate Cancer
Primary Outcomes
Description: Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen [PSA] response of > 50%). Will be conducted using the Cochran-Mantel-Haenszel test, with one-sided p-value of =< 0.05 considered significant.
Measure: Response rate (complete response + partial response) Time: Up to 2 yearsSecondary Outcomes
Description: Assessed by Prostate Cancer Working Group (PCWG)3. PFS to be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Progression-free survival (PFS) Time: From the time of randomization up to 2 yearsDescription: Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval. Comparison of time to PSA progression between arms will be conducted using the log-rank test.
Measure: Time to PSA progression Time: From the time of randomization up to 2 yearsDescription: Assessed by RECIST 1.1. rPFS will be estimated with the Kaplan Meier methodology. Median and event-free rate at selected time points will be provided with 95% confidence interval.
Measure: Radiographic progression-free survival (rPFS) Time: From the time of randomization up to 2 yearsDescription: Will be summarized according to treatment arm. For toxicity reporting, all adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Type of adverse events, intensity (grading), and attribution will be provided in a listing. All adverse events resulting in discontinuation, dose modification, and/or dosing interruption, and/or treatment delay of drug will also be summarized. Laboratory test results will be classified according to the CTCAE version 5.0.
Measure: Incidence of adverse events Time: Up to 2 yearsOther Outcomes
Description: OS will be estimated with the Kaplan Meier methodology. Comparison of OS between arms will be conducted using the log-rank test base on the intention-to-treat approach, where two treatment arms will be compared regardless of cross-over or any subsequent therapy.
Measure: Overall survival (OS) Time: From the time of randomization up to 2 yearsDescription: Gene mutation frequencies and mean +/- standard deviation of quantitative biomarkers will be summarized by arm and in overall population at baseline and/or at end of study.
Measure: Gene mutation frequencies Time: Baseline up to 2 yearsThe primary purpose of this study is to determine the effect of multiple once daily administrations of enzalutamide on the pharmacokinetics of a single dose of digoxin (P-glycoprotein (P-gp) substrate) and rosuvastatin (breast cancer resistant protein (BCRP) substrate) in participants with prostate cancer. This study will also evaluate the safety and tolerability of multiple once daily administrations of enzalutamide alone and in combination with a single dose of digoxin (P-gp substrate) and rosuvastatin (BCRP substrate) in participants with prostate cancer, as well, assess the pharmacokinetics of enzalutamide and its active metabolite.
NCT04094519 Prostate Cancer Drug: enzalutamide Drug: enzalutamide Placebo Drug: digoxin Drug: rosuvastatin MeSH:Prostatic Neoplasms
HPO:Prostate cancer Prostate neoplasm
Primary Outcomes
Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: maximum concentration (Cmax) Time: Up to Day 71
Description: AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast) Time: Up to Day 71
Description: AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) Time: Up to Day 71
Secondary Outcomes
Description: Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA).
An AE is any untoward medical occurrence in a participant administered an Investigational Product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of IP whether or not considered related to the IP.
An AE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures)or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Measure: Number of participants with Adverse Events (AEs) Time: Up to Day 101
Description: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs) Time: Up to Day 101
Description: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs) Time: Up to Day 101
Description: Number of participants with potentially clinically significant ECG values.
Measure: Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) Time: Up to Day 101
Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: maximum concentration (Cmax) Time: Up to Day 71
Description: AUCtau will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: area under the concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval (AUCtau) Time: Up to Day 71
Description: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) Time: Up to Day 71
3 ACTION: Phase I/II Trial of Abiraterone Acetate in Combination With Tildrakizumab (Anti-IL23 Targeting Monoclonal Antibody) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Primary Outcomes
Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: maximum concentration (Cmax) Time: Up to Day 71Description: AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast) Time: Up to Day 71Description: AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of Digoxin in combination with rosuvastatin in plasma: area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) Time: Up to Day 71Secondary Outcomes
Description: Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an Investigational Product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. An AE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures)or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Measure: Number of participants with Adverse Events (AEs) Time: Up to Day 101Description: Number of participants with potentially clinically significant laboratory values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs) Time: Up to Day 101Description: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs) Time: Up to Day 101Description: Number of participants with potentially clinically significant ECG values.
Measure: Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) Time: Up to Day 101Description: Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: maximum concentration (Cmax) Time: Up to Day 71Description: AUCtau will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: area under the concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval (AUCtau) Time: Up to Day 71Description: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measure: Pharmacokinetics (PK) of enzalutamide and its metabolite (N-desmethyl) in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) Time: Up to Day 71The purpose of this study is to find out the side effects and safety of a combination of the anti-IL23 targeting monoclonal antibody tildrakizumab in combination with abiraterone acetate in men with metastatic castration resistant prostate cancer and to determine the most appropriate dose of this combination. In the Phase I part of this study small groups of patients will be treated with increasing doses of tildrakizumab in combination with a fixed dose of abiraterone acetate(1000mg once daily). Once Phase I has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the Phase II part of the study. The Phase II part of the study will evaluate the optimized dose/schedule identified in Phase I of the study in patients with metastatic castration resistant prostate cancer.
NCT04458311 Metastatic Castration Resistant Prostate Cancer Drug: Abiraterone Acetate Drug: Tildrakizumab MeSH:Prostatic Neoplasms
HPO:Prostate cancer Prostate neoplasm
Primary Outcomes
Description: To determine a maximum tolerated dose (MTD) of tildrakizumab by establishing the dose at which the DLT rate is as close to the target DLT rate of 15% as possible, in combination with abiraterone at 1000 mg OD with prednisolone at 5 mg bid, and is deemed to be tolerable by the Safety Review Committee. This will be the RP2D for tildrakizumab.
Measure: Phase I - To describe the safety and tolerability of abiraterone acetate and tildrakizumab when given in combination. To establish a RP2D for tildrakizumab, in combination with abiraterone. Time: 12 months
Description: Antitumour activity will be defined by response rate on the basis of the following outcomes. If any of the following occur, patients will be considered to have responded:
PSA decline ≥ 50% criteria confirmed 4-weeks or later and/or,
Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or,
ONLY for patients with detectable circulating tumour cell (CTC) count of ≥ 5/7.5ml blood at baseline, conversion of CTC count to <5/7.5ml blood nadir.
Measure: Phase II - To determine the antitumour activity of tildrakizumab (at RP2D) in combination with abiraterone in men with mCRPC. Time: 12 months
HPO Nodes
Primary Outcomes
Description: To determine a maximum tolerated dose (MTD) of tildrakizumab by establishing the dose at which the DLT rate is as close to the target DLT rate of 15% as possible, in combination with abiraterone at 1000 mg OD with prednisolone at 5 mg bid, and is deemed to be tolerable by the Safety Review Committee. This will be the RP2D for tildrakizumab.
Measure: Phase I - To describe the safety and tolerability of abiraterone acetate and tildrakizumab when given in combination. To establish a RP2D for tildrakizumab, in combination with abiraterone. Time: 12 monthsDescription: Antitumour activity will be defined by response rate on the basis of the following outcomes. If any of the following occur, patients will be considered to have responded: PSA decline ≥ 50% criteria confirmed 4-weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or, ONLY for patients with detectable circulating tumour cell (CTC) count of ≥ 5/7.5ml blood at baseline, conversion of CTC count to <5/7.5ml blood nadir.
Measure: Phase II - To determine the antitumour activity of tildrakizumab (at RP2D) in combination with abiraterone in men with mCRPC. Time: 12 months