A Study of Multi-Modality Therapy for Very High-Risk Localized and Low-Volume Prostate Cancer

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Full Title

Metacure: Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

Purpose

Prostate cancer feeds on testosterone, the male hormone. The purpose of this study is to see if treatment with medications that reduce testosterone levels for a few months before surgery can, when used with each other and in combination with other therapies, completely eliminate visible prostate cancer from the body. The belief is that drugs that were developed to treat metastatic disease may be more effective when the tumor burden is low. Researchers will also look for biomarkers that predict how well a patient may respond to therapy, which will enable doctors to select the most appropriate treatments for patients in the future. This is the first clinical trial to assess such intensive hormonal therapy for prostate cancer in combination with multiple types of treatment with the goal of destroying all evidence of the cancer — not just extend survival.

The treatments in this study include a hormone injection given monthly or every three months, and the study drugs: abiraterone acetate, prednisone, and apalutamide. Radiotherapy will be recommended if a patient’s cancer has high-risk features when examined under the microscope after surgery. Researchers hope that combining the study drugs with surgery and radiation will get rid of the cancer and reduce prostate-specific antigen (PSA) to an undetectable level.

This study includes three groups: men with prostate cancer that has a high risk of returning after surgery or radiation therapy (group A); prostate cancer that spread to some other parts of the body at the time of diagnosis (B); and prostate cancer that started to spread a little in men who already had surgery to remove the prostate (C). For each group, the study drugs will be combined with other standard treatments for that type of cancer (surgery, stereotactic body radiotherapy, or both).

Patients in this study will be randomly assigned to receive apalutamide alone, or apalutamide plus abiraterone acetate and prednisone. Apalutamide is used to treat non-metastatic castration-resistant prostate cancer and is considered investigational in this study. Abiraterone acetate plus prednisone is used to treat prostate cancer but is not usually given with apalutamide. All three drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have prostate cancer that is confined to the prostate or has just begun to spread and is considered to have a very high risk of returning after initial treatment.
  • Patients may not have received prior treatment for prostate cancer, with the exception of prostate removal surgery in group C. Up to two months of previous hormonal therapy may be permitted.
  • Patients must have a blood testosterone level of 150 ng/dL or greater.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Howard Scher at 646-422-4323.

Protocol

17-646

Phase

II

Investigator