CLINICAL TRIAL

Apalutamide for Prostate Cancer

Recruiting · 18+ · All Sexes · San Francisco, CA

A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

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About the trial for Prostate Cancer

Treatment Groups

This trial involves 2 different treatments. Apalutamide is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Apalutamide
DRUG
+
EPI-7386
DRUG
Experimental Group 2
Abiraterone Acetate
DRUG
+
Prednisone or Prednisolone
DRUG
+
EPI-7386
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2019
Completed Phase 2
~380
Abiraterone Acetate
2015
Completed Phase 4
~1350
Prednisone or Prednisolone
2011
Completed Phase 3
~1260

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically confirmed prostate adenocarcinoma
Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
Must be able to swallow oral medicines
Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
You are willing and able to comply with the requirements of this protocol. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 3 Years 3 Months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 3 Years 3 Months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Apalutamide will improve 4 primary outcomes and 13 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of At 12 weeks.

Composite Response Rate
AT 12 WEEKS
Composite response rate at 12 weeks, defined as either 90 percent (%) reduction in prostate-specific antigen (PSA) level from baseline (PSA-90), or objective response (confirmed per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in participants with measurable disease, or both at 12 weeks.
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and Abiraterone
DAY 1 OF EACH CYCLE UP TO 3 CYCLES (EACH CYCLE OF 28 DAYS)
Tmax is defined as the time to reach maximum observed serum concentration of EPI-7386 and abiraterone.
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Apalutamide
DAY 1 OF EACH CYCLE UP TO 3 CYCLES (EACH CYCLE OF 28 DAYS)
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of EPI-7386 and apalutamide.
Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and apalutamide
DAY 1 OF EACH CYCLE UP TO 3 CYCLES (EACH CYCLE OF 28 DAYS)
Tmax is defined as the time to reach maximum observed serum concentration of EPI-7386 and apalutamide.
Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Abiraterone
DAY 1 OF EACH CYCLE UP TO 3 CYCLES (EACH CYCLE OF 28 DAYS)
The observed accumulation ratio for AUCtau, determined after multiple dose administration of EPI-7386 and abiraterone (C2D1/C1D1 and C3D1/C1D1).
Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Apalutamide
DAY 1 OF EACH CYCLE UP TO 3 CYCLES (EACH CYCLE OF 28 DAYS)
Cmax is defined as the maximum observed serum concentration of EPI-7386 and apalutamide.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get prostate cancer a year in the United States?

Around 100,000 cases are thought to be diagnosed and treated in the United States, or around 10% of all prostate cancers are thought to be diagnosed, which indicates that most prostate cancers are detected earlier and at an earlier stage. This is even more remarkable when looking at the differences in the age-standardized incidence rates for prostate cancer in different regions of the United States. This suggests that early diagnosis is a substantial driving factor in the prevention, treatment, and disease outcome for prostate cancer in the United States.

Anonymous Patient Answer

What are the signs of prostate cancer?

The signs and symptoms of prostate cancer are very nonspecific. Symptoms of prostate cancer can range from those related to benign prostatic hyperplasia alone to those related to the actual malignancy. The severity and rate of signs or symptoms can vary from an asymptomatic condition to an almost debilitating clinical syndrome, depending on the stage of disease. These symptoms and signs are the targets of present clinical practice guidelines for prostate cancer, which are based on the results of the latest available evidence in this field.

Anonymous Patient Answer

What causes prostate cancer?

As the name implies, [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is a cancer of the prostate gland. Although the exact cause of this disease is unknown, various risk factors for prostate cancer have been identified. Although prostate cancer has no known cause, environmental and lifestyle factors, including physical fitness, smoking, and alcoholic beverage consumption at an early age, appear to increase the risk of developing this disease.\n

Anonymous Patient Answer

What are common treatments for prostate cancer?

Prostate cancer is treated through a number of treatment methods, such as surgery, chemotherapy, radiation, and hormonal therapy. Lymph node dissection is sometimes the treatment of choice for patients with limited cancer in the context of localized, surgically treatable disease.

Anonymous Patient Answer

Can prostate cancer be cured?

More research is needed before the concept of cure can be substantiated. The issue of cure from prostate cancer has yet to be formally established. The cure rate estimates for prostate cancer from past studies have been substantially over-estimated. At this stage in time, only symptomatic treatment (and/or no treatment) can be claimed to be curative.

Anonymous Patient Answer

What is prostate cancer?

Prostate cancer is one of the most common cancers in the USA and causes death in more than 11,000 men each year. A diagnosis of PCa is strongly associated with an underlying problem such as benign prostatic hyperplasia. However, prostate cancer does not always require treatment and the optimal timing of its detection remains unclear. Clinicians should, therefore, ensure that the patient and the family are aware of the diagnosis and treatment implications and possible consequences of PCa.

Anonymous Patient Answer

How quickly does prostate cancer spread?

The majority of PCa cell spread to local lymph nodes or other distant organs during the initial stages of the disease. Data from a recent study of our study suggest that the progression and dissemination of PCa is a complex and incompletely understood process.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

The age of diagnosis of prostate cancer varies depending on the type of institution. In our population a mean age of 61.8 was observed among patients diagnosed at Community Hospitals, which is lower than previous reports. This age group is less likely of being diagnosed at Community Hospitals, as well as having less aggressive disease, making this sub-group comparable to men with prostate cancer diagnosed in the Private Hospital.

Anonymous Patient Answer

Does apalutamide improve quality of life for those with prostate cancer?

Recent findings indicates that apalutamide is associated with improved QOL even after only 7 days of initiation therapy and for this reason apalutamide is a relevant new option for the treatment of prostate cancer.

Anonymous Patient Answer

What is apalutamide?

Apalutamide is a promising new treatment option for castration resistant prostate cancer and has recently received approval by the FDA. As one of the first antiandrogens to be approved specifically in the treatment of prostate cancer without concurrent androgen deprivation, apalutamide is used in multiple clinical settings. Apalutamide is also used in androgen independent prostate cancer, in which other antiandrogens have failed, although it may have minimal clinical effect if given alone. In addition to its FDA-approved uses, apalutamide has been used in other clinical settings outside of the United States and is widely used in Europe.

Anonymous Patient Answer

Does prostate cancer run in families?

Data from a recent study further support the notion of a familial component in prostate cancer, though it is not clear that they are due to genetic transmission or are associated primarily with environmental exposures.

Anonymous Patient Answer

What is the latest research for prostate cancer?

It is hoped that more and more new facts about the prostate will be revealed through the year. However, the future will probably prove that it is a tough and often difficult path to be free from prostate cancer.

Anonymous Patient Answer
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