NCT04821622

Despite recent advances in the treatment of metastatic prostate cancer, more treatment options are needed.

The TALAPRO-3 study is researching whether talazoparib, the study drug, is safe and effective when given to men with metastatic Castration-Sensitive Prostate Cancer (mCSPC) along with enzalutamide, an approved treatment for this condition.

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Who may participate

Joining a clinical trial is an important and personal decision. Your doctor may have mentioned the TALAPRO-3 study, or perhaps you found your way here by yourself. Either way, thank you for your interest.

To qualify for this study, you may not have received certain anti-cancer treatments, such as:

platinum-based chemotherapy within the past 5 years
a novel hormone therapy (NHT), such as enzalutamide, or abiraterone/prednisone, or apalutamide if taken for more than 3 months
a PARP inhibitor (PARPi)
androgen deprivation treatment for more than 3 months

In addition, TALAPRO-3 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 Castration-Sensitive Prostate Cancer (mCSPC)

Age

18+ years

DDR Deficiencies

ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C

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.

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What to expect

To see if you qualify for TALAPRO-3, you must attend a pre-screening visit as a first step at the study clinic. If it is determined that you have the required DDR deficiencies, you may attend further screening visits. 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 a maximum of six capsules by mouth, once a day, for an average of 3 years (this may be longer or shorter, depending on how your cancer responds to study treatment). You will be given either:

talazoparib (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 study treatment

About 3 years

Number of study visits

Up to 25

Long-term follow up

Clinic or phone contact every 8 to 12 weeks unless imaging is required

About metastatic Castration-Sensitive Prostate Cancer (mCSPC)

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 surgery or radiation to remove the cancer when it is localized to the prostate; it may also 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, or if it is first diagnosed when it has already spread beyond the prostate, the condition is known as metastatic Castration-Sensitive Prostate Cancer, however it may still be responsive to hormone therapy.

About DNA Damage Response (DDR)

DNA is found in all 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 one of 12 genes important for DNA damage response, such as: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C.

Therefore, you may 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 a biopsy (a procedure to remove a piece of tissue) or from tumor tissue that was previously obtained.