ARN-509 (Phase 2) for Prostate Cancer

1
Effectiveness
1
Safety
NCT01171898, Ann Arbor, MI
Prostate Cancer+1 More
ARN-509 (Phase 2) - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a drug called ARN-509 can be used to treat prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether ARN-509 (Phase 2) will improve 1 primary outcome and 4 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Week 12.

Year 7
Phase 1 and 2: Median Time to PSA Progression
Phase 1 and 2: Objective Response Rate
Phase 1 and 2: Progression-free Survival (PFS)
Phase 2: Median Metastasis-Free Survival (MFS)
Week 12
Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

4 Treatment Groups

No Control Group
Treatment-naive metastatic CRPC (Phase 2)

This trial requires 127 total participants across 4 different treatment groups

This trial involves 4 different treatments. ARN-509 (Phase 2) is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment-naive metastatic CRPC (Phase 2)
Drug
Participants with treatment-naive metastatic CRPC will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.
Dose Escalation Cohort (Phase 1)
Drug
ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily. Once Recommended Phase 2 Dose (RP2D) has been selected, Phase 1 participants being treated at the lower dose levels will be allowed to escalate to the RP2D level at the discretion of the primary investigator.
Non-metastatic CRPC (Phase 2)
Drug
Participants with non-metastatic, treatment-naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) will be enrolled. ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
Post-abiraterone metastatic CRPC (Phase 2)
Drug
Participants with metastatic CRPC that are chemotherapy-naive, but have been previously treated with abiraterone will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 7 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 7 years for reporting.

Closest Location

NCT01171898 - Ann Arbor, MI

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
Castrate levels of serum testosterone of less than or equal to 50 ng/dL
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
A life expectancy of at least 3 months
NON-METASTATIC CRPC
Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value >=8 ng/mL within the last 3 months or PSA Doubling Time <=10 months

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?

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Although the number of cases of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) reported to the National Cancer Institute was relatively stable over this period, there was a marked increase in recorded incidence of metastases between 1987 and 1992; this suggests the need for further studies to refine the risk assessment for localized prostate cancer. Also, in the general population the detection rate of prostate cancer has increased over this period.

Unverified Answer

What are common treatments for prostate cancer?

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Treatment of prostate cancer is complex and tailored to the individual patient at a time when the prognostic factors have been considered for an individual patient. One of the most commonly used treatments for prostate cancer is radiotherapy and the use of androgen deprivation therapy is another popular treatment for prostate cancer as well as the use of other androgen antagonists such as orteronel and bicalutamide.

Unverified Answer

What causes prostate cancer?

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A causal connection to lifestyle factors, such as smoking, is strongly supported. The current recommendations by the USPSTF and the American Academy of Family Physicians are reasonable in regards to minimizing smoking and limiting alcohol. Dietary habits such as a healthy diet and exercise are also shown to be key factors in prostate cancer prevention. However, other lifestyle factors, such as caffeine and obesity, may not play a role; they should therefore be questioned while taking into account the possible deleterious effects.

Unverified Answer

What is prostate cancer?

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Prostate cancer occurs when cells in the prostate grow uncontrollably and then form a mass. Once a prostate tumor emerges in one of the prostate glands it can quickly spread to nearby tissue. Prostate cancer often presents with urinary symptoms and frequent urination, painful urination or painful ejaculation and it is more likely to be high grade. The most common form is known as prostatitis or inflammation. Prostatic cancer can be detected using a digital rectal exam, computer-enhanced or transrectal ultrasound, a CT scan of the pelvis or MRI of the whole body. If a mass can be detected through a rectal exam prostatic cancer occurs in less than 2% of cases.

Unverified Answer

What are the signs of prostate cancer?

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There are many signs of prostate cancer that include increased frequency and duration of urination, pain on urination and urgency. Abnormalities in volume and consistency of bladder and prostatic fluid, however, are not signs of prostate cancer.

Unverified Answer

Can prostate cancer be cured?

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In this article the question is answered, 'can prostate cancer be cured?' There is no such thing; treatment and diagnosis and management cannot cure a disease by itself. Effective treatment of concurrent diseases, as well as adherence to rigorous treatment protocols of prostate cancer is essential in reducing mortality, disease recurrence, prostate cancer-related morbidity, and disease-free survival from prostate cancer.

Unverified Answer

What are the common side effects of arn-509 (phase 2)?

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Arn-509 is an orally bioavailable, safe, and tolerable investigational drug candidate that is being used in the treatment of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Unlike many other investigational antiandrogens and antiestrogens, arn-509 reversibly and selectively induces profound aromatase inhibition in prostate cancer cells, as well as in several human prostate tumor xenografts, without concomitant estrogenic or antiestrogenic effects.

Unverified Answer

What is the average age someone gets prostate cancer?

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There is a clear increase in the average age patients are diagnosed with prostate cancer in the United States. This rise is expected as younger men are more likely to be screened, and as treatment is becoming more available. However, the average age at initial diagnosis of prostate cancer remains unchanged at 72 years. The shift to earlier detection is in part driven by increased use of the PSA test and subsequent PSA trend screening. In the foreseeable future, the average age of prostate cancer diagnosis will likely increase due to the increase in use of screening and diagnostic testing for prostate cancer.

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

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The number of discoveries in [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) research has dramatically increased. A major focus in prostate research should continue to be directed toward the development of drugs that can be used in conjunction with existing standard treatments to improve outcome. In particular, combination therapy may be superior to the standard method of treating patients with high-risk disease.

Unverified Answer

How does arn-509 (phase 2) work?

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ARN-509 treatment demonstrates an increase in prostate-specific antigen levels in patients with previously untreated prostate cancer with an indication of biochemical response. In addition to the clinical benefit of a reduction in progression, the benefit/risk ratio showed the ability to reduce castration resistance. This data suggests a possible applicability for this drug in the management of androgen-dependent prostate cancer.

Unverified Answer

Does prostate cancer run in families?

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There has been little information published from genome-wide association studies to support the existence of genetic susceptibility factors or modifier gene effects for familial prostate cancer. We have evaluated the family history of prostate cancer in a large, population-based sample in Canada.

Unverified Answer

What are the latest developments in arn-509 (phase 2) for therapeutic use?

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Results of phase II trials indicate that arn-509 is well tolerated in this patient population and has activity of a novel type. Further development is planned for the therapeutic use of this agent.

Unverified Answer
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