Study on Apalutamide Plus Hormone Therapy Versus Hormone Therapy Alone for Metastatic Hormone-Sensitive Prostate Cancer
Sponsor: Aragon Pharmaceuticals, Inc.
ClinicalTrials ID:NCT02489318
This clinical trial is testing whether adding the drug apalutamide to standard hormone therapy can improve outcomes for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to see if this combination can help patients live longer or delay the progression of their cancer.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining apalutamide with standard hormone therapy (ADT) is more effective than hormone therapy alone in helping patients with metastatic hormone-sensitive prostate cancer (mHSPC) live longer or slow down the progression of their cancer. The study will monitor patients' health and safety throughout the trial.
Description
This study involves randomly assigning participants to receive either apalutamide with hormone therapy or hormone therapy alone. Neither the participants nor the researchers will know which treatment each participant is receiving. The study will take place in multiple countries and centers and includes several phases:
- Screening Phase: Up to 28 days before participants are randomly assigned to a treatment group.
- Treatment Phase: Participants will receive treatment in 28-day cycles until their cancer progresses or they experience unacceptable side effects.
- End of Treatment Phase: Lasts until 30 days after the final dose of the study drug.
- Survival Follow-up Phase: Continues after treatment ends to monitor participants' health.
If the study shows positive results, participants may have the option to join an Open-label Extension Phase, where they can receive apalutamide for about 3 years. If they continue to benefit, they may enter a Long-term Extension Phase. Participants' safety will be closely monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate adenocarcinoma.
- Cancer has spread to the bones, confirmed by scans. If only one bone lesion is present, further confirmation is needed.
- Good overall health with an ECOG performance status of 0 or 1.
- If previously treated with docetaxel, must have received up to 6 cycles, with the last dose given within 2 months before joining the study, and shown stable disease or better.
- Allowed prior treatments include one course of radiation or surgery, completed before joining the study, and up to 6 months of hormone therapy.
- Previous treatments for localized prostate cancer must have been completed at least 1 year before joining the study, including up to 3 years of hormone therapy and other therapies like radiation or surgery.
Exclusion Criteria
- Prostate cancer with small cell, ductal, or neuroendocrine features.
- Known cancer spread to the brain.
- Only lymph nodes or only liver/lung metastases.
- Other cancers within 5 years, except certain skin or bladder cancers.
- Previous treatment with certain advanced prostate cancer drugs or therapies.
- History of seizures or taking medications that lower the seizure threshold.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Homewood | Alabama | ||
| Tucson | Arizona | ||
| San Bernardino | California | ||
| San Diego | California | ||
| Denver | Colorado | ||
| Norwalk | Connecticut | ||
| Fort Myers | Florida | ||
| Chicago | Illinois | ||
| Fort Wayne | Indiana | ||
| Jeffersonville | Indiana |
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