50 Participants Needed

Apalutamide Before Surgery for Prostate Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

JW

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

My scans show no signs of cancer spread, and any suspicious lymph nodes are smaller than 10 mm.
Serum bilirubin < 1.5 x upper limit of normal (ULN); Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible
Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
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Exclusion Criteria

I have had serious heart issues like a heart attack or severe heart failure recently.
My high blood pressure is under control with medication.
Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive apalutamide orally daily for 24 weeks prior to radical prostatectomy

24 weeks

Surgery

Participants undergo radical prostatectomy within 2 weeks of completing apalutamide treatment

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biochemical recurrence and quality of life assessments

12 months

Treatment Details

Interventions

  • Apalutamide
  • Radical Prostatectomy
Trial OverviewThe trial is testing apalutamide's effectiveness in treating prostate cancer before surgical removal of the prostate. Apalutamide is a hormone therapy that lowers androgen levels which may reduce the need for radiation post-surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (apalutamide, radical prostatectomy)Experimental Treatment3 Interventions
Patients receive apalutamide PO daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy.

Apalutamide is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Erleada for:
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Metastatic castration-sensitive prostate cancer (mCSPC)
🇪🇺
Approved in European Union as Erleada for:
  • 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

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a phase III study (TITAN) involving men with metastatic castration-sensitive prostate cancer, adding apalutamide to androgen deprivation therapy significantly improved median radiographic progression-free survival and overall survival.
Apalutamide was found to maintain health-related quality of life and had a safety profile similar to that of placebo when combined with androgen deprivation therapy, expanding treatment options for this patient group.
Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer.Hoy, SM.[2021]
Apalutamide is an oral androgen receptor inhibitor that effectively blocks androgen effects, and it received its first global approval in February 2018 for treating non-metastatic castration-resistant prostate cancer (nmCRPC).
Currently, apalutamide is being tested in phase III trials for various prostate cancer stages, including metastatic castration-resistant prostate cancer and high-risk localized prostate cancer, indicating its potential for broader applications in prostate cancer treatment.
Apalutamide: First Global Approval.Al-Salama, ZT.[2019]
In a study involving 57 patients with metastatic castration-resistant prostate cancer (mCRPC), the combination of apalutamide with abiraterone acetate and prednisone was well tolerated and demonstrated significant antitumor activity, particularly in patients who had not previously been treated with androgen receptor inhibitors.
While apalutamide reduced the systemic exposure to prednisone by 61%, no significant adverse events related to mineralocorticoid excess were observed, indicating a favorable safety profile for this combination therapy.
Pharmacokinetics, Safety, and Antitumor Effect of Apalutamide with Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer: Phase Ib Study.Posadas, EM., Chi, KN., de Wit, R., et al.[2021]

References

Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer. [2021]
Apalutamide: First Global Approval. [2019]
Pharmacokinetics, Safety, and Antitumor Effect of Apalutamide with Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer: Phase Ib Study. [2021]
Apalutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. [2020]
Phase II open-label study investigating apalutamide in patients with biochemical progression after radical prostatectomy. [2021]
Perioperative adverse events and functional outcomes following open and robot-assisted prostatectomy in patients over age 70. [2021]
Long-term adverse effects after retropubic and robot-assisted radical prostatectomy. Nationwide, population-based study. [2021]
How does robot-assisted radical prostatectomy (RARP) compare with open surgery in men with high-risk prostate cancer? [2013]
Is robot-assisted radical prostatectomy safe in men with high-risk prostate cancer? Assessment of perioperative outcomes, positive surgical margins, and use of additional cancer treatments. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Robotic vs. Retropubic radical prostatectomy in prostate cancer: A systematic review and an meta-analysis update. [2022]
Apalutamide-induced lichenoid reaction in a patient with non-metastatic castrate-resistant prostate cancer. [2023]
Prospects of Treating Prostate Cancer through Apalutamide: A Mini-Review. [2022]