Who may participate

Joining a clinical trial is an important and personal decision. Your doctor may have mentioned the TALAPRO-2 study, or perhaps you found your way here by yourself. Either way, thank you for your interest.  

To qualify for this study, you must not have received certain treatments, such as; 

  • systemic cancer treatment (treatment that enters the bloodstream to reach cells all over the body) for mCRPC. This does not include androgen deprivation therapy and first-generation anti-androgens 

  • enzalutamide, apalutamide, or darolutamide 

  • platinum-based chemotherapy within the past 6 months  

In addition, TALAPRO-2 may be a good fit if you are willing to provide saliva, blood, and tumor tissue samples for genetic testing.  The study team will determine if you have a mutation in selected genes important for DNA damage response, and you are otherwise in reasonably good health.  

There are other requirements for participation in the study. The study doctor will explain these to you. 

Condition
metastatic Castrate Resistant Prostate Cancer (mCRPC)
The disease, disorder, syndrome, illness, or injury that is being studied.
Age
18 and older
The age a person must be to participate in a clinical trial.
DDR deficiencies
BRCA2, BRCA1 and others
DDR stands for DNA damage response. The DDR deficiencies listed here are the DNA defects required to be able to participate in this study.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

To see if you may qualify for TALAPRO-2, you will attend one or more screening visits at the study clinic. If you choose to sign the informed consent document, you will be asked health-related questions and will have several study assessments, tests and procedures to help determine if you’re eligible to participate. 

If you qualify, you can expect to take six capsules by mouth, once a day, for an average of 85 weeks (this may be longer or shorter, depending on how your cancer responds to study treatment). You will either be given: 

  • the study drug + enzalutamide, or  

  • placebo (inactive medicine) + enzalutamide 

Neither you nor the study team will know which study treatment you are taking. They will monitor how you are responding to the study treatment during your regular visits at the study clinic. 

After you stop taking your study treatment, the study team will continue to contact you by telephone to see how you are doing. 

Length of treatment
About 85 weeks
Length of treatment is the length of time the study participants will receive the study treatment. This may be longer or shorter, depending on how your cancer responds to study treatment.
Number of study visits
Up to 25
Each clinical trial’s design specifies the number of study visits and the total length of the trial. This may be longer or shorter, depending on how your cancer responds to study treatment.
Long-term follow up
Clinic or phone contact every 12 weeks unless radiography imaging is required
Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the treatment. This long-term follow up is to see how you are doing after the study treatment is discontinued.

About metastatic Castration Resistant Prostate Cancer (mCRPC)

Prostate cancer occurs when the cells within the prostate gland start to multiply out of control. It is the second most common cancer in American men, after skin cancer. 

Initial treatment may involve medication that aims to keep levels of the male sex hormones low. This is because prostate cancer growth is often driven by male sex hormones, including testosterone. 

If the cancer continues to spread to other parts of the body and hormone therapy no longer stops or slows the cancer, the condition is known as metastatic castration resistant prostate cancer. 

About DNA Damage Response (DDR)

DNA is found in all your cells and is arranged into structures called genes. Different genes contain information to produce different proteins. Sometimes DNA can have certain defects or errors. Some proteins are important to help cells find and fix errors in other genes (DNA damage response). 

To enroll in this study, you must have a DNA defect in at least one gene important for DNA damage response, such as, BRCA2 or BRCA1. 

Therefore, you will be asked to provide a blood and tumor sample to determine if your tumor DNA has any of these defects. The tumor sample will be provided either through biopsy (a procedure to remove a piece of tissue) or from tumor tissue that was previously obtained.