Active not recruitingPHASE3INTERVENTIONAL

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

This study is for men with metastatic castration-resistant prostate cancer (mCRPC), which means their prostate cancer has spread and is no longer responding to standard hormone therapy. We are testing a new combination of two medicines: talazoparib and enzalutamide. Some men will receive both drugs, while others will receive enzalutamide with a dummy pill (placebo). The main aim is to see if the new combination can help men live longer without their cancer getting worse, compared to enzalutamide alone. Before the main study, a small group of men will receive the combination to make sure the starting dose is safe. This research could help find better ways to treat this type of prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

1,054

Start

18 Dec 2017

Estimated completion

30 Jun 2027

mCRPC

Results

Results from this study

Posted January 2024

Results have been published for this study.

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1

An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.

Full results on the registry

What is this study about?

This research is looking into new ways to treat advanced prostate cancer that has spread in the body and is no longer responding well to usual hormone treatments. This type of cancer is called metastatic castration-resistant prostate cancer, or mCRPC. Currently, one treatment option is a medicine called enzalutamide. This study wants to see if adding another drug, called talazoparib, to enzalutamide works better than having enzalutamide on its own.

Imagine the study in two main parts. The first small part is like a careful warm-up, where a few men will take the new combination to check that the dose is safe and causes no unexpected problems. Once the doctors are happy with the dose, the main study begins. This larger part will involve more men and will compare the new combination to enzalutamide with a placebo (a dummy pill).

The goal of this study is to find out if combining talazoparib with enzalutamide can slow down the cancer's growth or spread more effectively than enzalutamide alone. This is really important because it could lead to new and more effective treatments for men living with mCRPC, potentially improving their quality of life and outcomes.

Key takeaways

This study is testing a new combination treatment for advanced prostate cancer that has spread.
It aims to see if adding talazoparib to enzalutamide is more effective than enzalutamide alone.
Participation involves taking daily medication and regular check-ups with scans and blood tests.
Your health and safety will be closely monitored by the study team.
You can stop participating in the study at any time.
The findings could lead to better treatments for men with mCRPC.

Who may be eligible?

To be considered for this study, you would need to be a man aged 18 or older with prostate cancer that has spread to other parts of your body (metastatic) and is no longer responding to hormone treatment. Your cancer must be an adenocarcinoma, which is the most common type of prostate cancer, and you should not have severe symptoms from the spread of your cancer. Your testosterone levels must be low, either from surgery or medication you’re already taking.

We would also need to see that your cancer has started to grow despite current treatments. This might be shown by your PSA levels going up, or scans showing your cancer has progressed in your bones or other soft tissues. You would need to be generally well enough to take part in a study, as assessed by a doctor, and expected to live for at least another year. You must also be able to swallow the study medication.

For the main part of the study, we would also look at your genes to see if you have certain changes (called DDR mutations), and we'd ask for a saliva sample to help with this. You'd also need to agree to use contraception during the study and for a few months afterwards if you are sexually active with a female partner who could become pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Do you have prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone treatment?
Are you currently having treatment that keeps your testosterone levels low?
Are your cancer symptoms mild, or do you have none?
Are you generally well enough for a clinical study?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve taking either two medicines (talazoparib and enzalutamide) or enzalutamide along with a dummy pill (placebo). You won't know which group you are in, and neither will your doctor, which helps to make the results fair. You'll have regular hospital visits, where doctors will check your general health, do blood tests, and perform scans to see how the treatment is working and monitor for any side effects. You might also be asked to provide saliva samples.

The study involves taking daily medication. The total length of your participation can vary, but you will continue treatment for as long as it is benefiting you and you are tolerating it well. Even after you stop taking the study medication, there will be follow-up appointments to monitor your health and gather important information about your progress. You will be given clear instructions on what to expect at each stage.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks to consider. A potential benefit of joining this study is that you might receive a new combination treatment that could work better than standard care for your type of prostate cancer, potentially slowing its progress. However, there's also a chance you might receive the placebo alongside enzalutamide. All medicines can have side effects, and the study doctors will carefully monitor you for any unwanted effects of the treatment, which will be explained to you in detail. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your future medical care. Your safety and well-being are the top priority throughout the study.

Locations (368)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alaska Urological Institute dba Alaska Clinical Research Center
Verified postcode
Anchorage, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Verified postcode
Chandler, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Verified postcode
Gilbert, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Verified postcode
Mesa, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Verified postcode
Mesa, United States
Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
Verified postcode
Scottsdale, United States
Arizona Urology Specialists
Verified postcode
Tucson, United States
Arizona Urology Specialists
Verified postcode
Tucson, United States
Beverly Hills Cancer Center
Verified postcode
Beverly Hills, United States
South County Hematology/Oncology
Verified postcode
Chula Vista, United States
Sharp Rees-Stealy
Verified postcode
Chula Vista, United States
Glendale Adventist Medical Center
Verified postcode
Glendale, United States

Common questions

What is mCRPC?

mCRPC stands for metastatic castration-resistant prostate cancer. It means your prostate cancer has spread to other parts of your body (metastatic) and is no longer being controlled by standard hormone treatments (castration-resistant).

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers fairly compare the new treatment to no additional treatment.

Why do I need to use contraception?

Some study drugs can harm an unborn baby. Using contraception ensures safety for any potential pregnancies during and after your participation.

What is a 'DDR mutation'?

DDR mutations are changes in certain genes that are involved in repairing damaged DNA. These mutations can sometimes affect how cancers respond to specific treatments.

Will I know which treatment I am getting?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you are receiving the active combination treatment or enzalutamide with a placebo. This helps ensure unbiased results.