In a nutshell
This phase 2 trial aims to evaluate combinations of hormone therapies, a steroid drug, an immunotherapy drug, and chemotherapy in the treatment of metastatic castration-resistant prostate cancer. The main outcome to be investigated is overall survival (time from treatment until death from any cause). The trial is recruiting in Houston, Texas, USA.
The details
Hormone therapy is the standard of care for advanced prostate cancer, including prostate cancer that has spread to distant organs (metastatic). Over time, many men stop responding to hormone therapy, resulting in the cancer progressing and continuing to spread. This is known as metastatic castration-resistant prostate cancer (mCRPC).
There are a number of alternative treatment options for mCRPC. Some of these include secondary hormone therapies, such as apalutamide (ARN-509) or abiraterone acetate (Zytiga). Steroid drugs, such as prednisone (Deltasone) are usually given with hormone therapy to alleviate side effects. Immunotherapy drugs, such as ipilimumab (Yervoy), use the patient’s own immune system to recognize and destroy cancer cells. Chemotherapies, such as cabazitaxel (Jevtana) and carboplatin (paraplatin), are another commonly prescribed treatment option for mCRPC.
This study will examine different combinations of these treatments in prolonging survival in men with progressing mCRPC.
Who are they looking for?
This study will recruit about 265 men with metastatic prostate cancer, no longer responding to standard hormone therapy. Participants should have very low testosterone levels (near castration level). Cancer should be progressing based on blood tests or bone metastases. Full blood counts will be evaluated before taking part.
Participants cannot take part in the trial if they have previously undergone treatment with any of the drugs used in the study or with similar experimental or systemic therapies. Previous radiation therapy is permitted, provided it was delivered to a single site and was completed at least 6 weeks before taking part. Previous use of steroid drugs is acceptable, as is ongoing use depending on the dosage. Participants should not have hepatitis, HIV, or an active infection, immunodeficiency or autoimmune disorder. Participants should not have uncontrolled high blood pressure, an increased risk for heart or blood vessel disease, a history of seizures, a gastrointestinal disorder, or present with any significant medical or psychiatric illnesses.
How will it work
All participants will begin the study in Group 1. The first treatment will involve apalutamide (daily oral dose of 240 mg), abiraterone acetate (daily oral dose of 1000 mg), and prednisone (oral dose of 5 mg twice daily). After 8 weeks of treatment in Group 1, participants will have blood drawn for testing. The results of the blood test will determine whether the patient will move on to Group 2 or Group 3.
If participants are eligible to move on to Group 2, they will be randomly assigned to either continue the same treatments or additionally receive ipilimumab (by injection into the vein every 3 weeks). If participants are eligible to move on to Group 3, they will receive apalutamide, abiraterone acetate, and prednisone with the chemotherapies carboplatin and cabazitaxel (both by injection into the vein every 3 weeks). Treatment cycles last 21 days and are repeated until disease progression or unacceptable side effects are observed.
Participant will have a physical exam and blood tests on Day 1 of Cycles 1, 2, 4, 5, 6, 7, 8, 9, and 10, then every 2 cycles after that for one year, then every 4 cycles after that. Participants will also have a physical exam, a blood test, a CT or MRI scan, and a bone marrow tissue sample on Day 15 of Cycle 3. Additional blood tests measuring biomarkers (markers in the blood that will determine which group the participant will join) will be carried out regularly in each treatment group. Participants will have the opportunity to discuss side effects during every visit. About 14 days after participant's last dose of the study drugs, they will return to the clinic for an end-of-treatment visit. There will also be long-term follow-ups every 6 months after the end of treatment.
Clinical trial locations
| Type: | Interventional |
| Participants: | 196 |
| Study ID: | NCT02703623 |
