Apalutamide Before Surgery for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect hormone levels or have a history of seizures, you may need to discuss this with the trial team.
What data supports the effectiveness of the drug Apalutamide for prostate cancer?
Apalutamide has been shown to significantly improve survival and delay disease progression in patients with different types of prostate cancer, such as metastatic castration-sensitive and non-metastatic castration-resistant prostate cancer, when combined with androgen deprivation therapy. It has also been effective in maintaining quality of life and is generally well tolerated.12345
Is Apalutamide safe for use in humans?
The studies reviewed focus on the safety of different surgical methods for prostate cancer, such as robot-assisted radical prostatectomy (RARP), and suggest that RARP is a safe option for men with high-risk prostate cancer. However, they do not provide specific safety data on Apalutamide itself.678910
How is the drug apalutamide used before surgery for prostate cancer different from other treatments?
Apalutamide is unique because it is an oral drug that specifically targets androgen receptors, which are proteins that help prostate cancer cells grow. This drug is typically used for advanced prostate cancer, but using it before surgery for prostate cancer is a novel approach that may help shrink tumors and improve surgical outcomes.1231112
Research Team
John W Davis
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Men with intermediate-risk prostate cancer, suitable for surgery, and no metastases. They must have a testosterone level above 200 ng/mL, agree to use contraception during the trial and for 3 months after, be able to swallow tablets, and not have other serious health issues or another active malignancy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive apalutamide orally daily for 24 weeks prior to radical prostatectomy
Surgery
Participants undergo radical prostatectomy within 2 weeks of completing apalutamide treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including biochemical recurrence and quality of life assessments
Treatment Details
Interventions
- Apalutamide
- Radical Prostatectomy
Apalutamide is already approved in United States, European Union for the following indications:
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator