What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), can lead to side effects including hot flashes, reduced libido, erectile dysfunction, fatigue, and loss of bone density. Treatments like enzalutamide and abiraterone, used after ADT, may cause fatigue, hypertension, and increased risk of diabetes. Zoledronic acid, used for bone metastases, can cause bone pain, renal toxicity, and osteonecrosis of the jaw.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve hormonal manipulation, similar to the focus of the Zolpidem trial on androgen deprivation therapy (ADT). Notable drugs include enzalutamide, an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway, and abiraterone, which inhibits androgen production. These treatments are used in castration-resistant prostate cancer (CRPC) and have shown efficacy in improving overall survival and progression-free survival in clinical trials.

What other types of research exist?

Promising alternatives to Zolpidem for prostate cancer patients undergoing ADT include melatonin and ramelteon. Melatonin is a natural hormone that regulates sleep-wake cycles and has minimal interaction with hormonal therapies. Ramelteon is a melatonin receptor agonist that mimics the action of melatonin and is effective in treating insomnia without significant hormonal interactions.

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Sedative-Hypnotic

Zolpidem Pharmacokinetics in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Phase 1

Waitlist Available

Led By William D Figg, Pharm.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0 to 1

Patients must have progressive prostate cancer as indicated by either PSA progression (PSA progression is defined as two consecutively rising PSAs above the nadir post- definitive therapy and an absolute value greater than 1.0 ng/mL separated by at least 2 weeks) or radiographic progression based on RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3).

Must not have

Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how a sleep medication called zolpidem works in men with prostate cancer and healthy women. It aims to see if hormone levels affect how the drug is processed in the body. Participants will take the medication and have their blood tested to measure drug levels. Zolpidem is a widely prescribed medication used for treating sleep disorders.

Who is the study for?

Men over 18 with prostate cancer planning to undergo androgen deprivation therapy, and healthy women over 18 can join. Participants must have normal organ function, not be on certain medications or have other cancers, serious illnesses, or psychiatric conditions that could affect the study.

What is being tested?

The trial is testing how castration affects the levels of Zolpidem in men with prostate cancer compared to its levels in healthy women. Men will take Zolpidem before and after their testosterone-lowering treatment; both groups will stay overnight for monitoring.

What are the potential side effects?

Zolpidem may cause drowsiness, dizziness, headache, gastrointestinal issues like nausea or diarrhea, allergic reactions, daytime drowsiness affecting alertness and coordination (increasing fall risk), and sometimes memory loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My prostate cancer is getting worse, shown by rising PSA levels or scans.

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I can swallow pills.

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My blood tests show normal organ function and healthy blood cell counts.

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I am planning to undergo hormone therapy for my cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart problems or recent heart attacks.

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I do not have any serious illnesses that would stop me from following the study's requirements.

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I am not on medications that affect zolpidem metabolism.

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I have no liver, stomach, or other conditions affecting medication processing.

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I have not received chemotherapy for prostate cancer.

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I am at risk of falling or have recently had a fracture.

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I am currently being treated for Hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in AUC values in males between pre-ADT and post-ADT

Secondary study objectives

Comparison of AUC values between post-ADT males and healthy female subjects

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Zolpidem pre and post castrationExperimental Treatment1 Intervention

5 mg oral dose of zolpidem prior to undergoing ADT followed by 5 mg oral dose of zolpidem after ADT and testosterone reaches castrate levels

Group II: FemaleActive Control1 Intervention

Single 5 mg oral dose of zolpidem

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zolpidem

2003

Completed Phase 4

~2490

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT) and androgen receptor inhibitors (ARIs), work by targeting the hormonal pathways that prostate cancer cells depend on for growth. ADT reduces testosterone levels, while ARIs like enzalutamide block the androgen receptor and abiraterone inhibits androgen production. These treatments are essential as they effectively slow down or stop the progression of prostate cancer by depriving cancer cells of the hormones they need to proliferate.

Functional impact of androgen-targeted therapy on patients with castration-resistant prostate cancer.Does testosterone mediate the relationship between vitamin D and prostate cancer? A systematic review and meta-analysis protocol.