20 Participants Needed

Enzalutamide Implants for Prostate Cancer

BW
PM
Overseen ByPamela Munster, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have ongoing hormonal therapy for prostate cancer or use 5 alpha reductase inhibitors within 3 months of starting the trial.

What data supports the effectiveness of the drug Enzalutamide for prostate cancer?

Research shows that Enzalutamide, when used for prostate cancer, significantly improves survival rates and reduces cancer markers in patients, especially those with castration-resistant prostate cancer. It has been shown to prolong survival compared to older treatments and is well-tolerated in clinical trials.12345

Is enzalutamide generally safe for humans?

Enzalutamide has been studied in several clinical trials for prostate cancer and generally shows a favorable safety profile. Common side effects include fatigue, diarrhea, back pain, and hot flashes, with some reports of high blood pressure and rare seizures.12367

How is the drug enzalutamide unique for prostate cancer treatment?

Enzalutamide is unique because it is an androgen receptor inhibitor that blocks several steps in the androgen receptor signaling pathway, which is crucial for prostate cancer progression. Unlike traditional treatments, it is administered orally and has been shown to significantly improve survival rates and delay the need for chemotherapy in men with metastatic castration-resistant prostate cancer.12389

What is the purpose of this trial?

The study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy.

Research Team

PP

Peter Pinto, MD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Men over 21 with prostate cancer, a Gleason score of at least 3+4, and PSA levels ≥3 ng/mL. They must be fit for surgery, have no history of prostate infection in the last two years or hormonal therapy within three months. No metallic implants that affect MRI quality or conditions preventing surgery are allowed.

Inclusion Criteria

I am fully active or can carry out light work.
I am at least 21 years old.
PSA greater or equal to 3 ng/mL within 3 months of screening
See 10 more

Exclusion Criteria

My cancer has spread to other parts of my body.
Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images
I am currently on hormone therapy for prostate cancer or was on it less than 3 months ago.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo multiparametric MRI of the prostate

1 week
1 visit (in-person)

Treatment

Placement of drug eluting Enolen implants and follow-up MRI

6-12 weeks
2 visits (in-person)

Surgery

Participants undergo standard of care radical prostatectomy

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including clinical labs and quality of life questionnaires

6-12 weeks
Multiple visits (in-person)

Treatment Details

Interventions

  • Enzalutamide
Trial Overview The trial is testing Enolen implants to see if they safely deliver anti-androgen medication directly to the prostate before radical prostatectomy. Participants will undergo MRI post-treatment to assess the implant's effects.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Enolen (tm)Experimental Treatment1 Intervention
Enolen (tm) implants containing enzalutamide

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇪🇺
Approved in European Union as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇨🇦
Approved in Canada as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)
🇯🇵
Approved in Japan as Xtandi for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
  • Non-metastatic castration-resistant prostate cancer (nmCRPC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alessa Therapeutics Inc.

Lead Sponsor

Trials
3
Recruited
60+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Enzalutamide is an effective androgen receptor inhibitor that improves overall survival in patients with metastatic castration-resistant prostate cancer, showing a 4.8-month survival benefit in those previously treated with docetaxel, as demonstrated in the Phase III AFFIRM trial.
The FDA has expanded enzalutamide's approval to include first-line treatment for metastatic castration-resistant prostate cancer in patients who have not yet received chemotherapy, and it is associated with an acceptable safety profile.
Enzalutamide for patients with metastatic castration-resistant prostate cancer.Ramadan, WH., Kabbara, WK., Al Basiouni Al Masri, HS.[2020]
Enzalutamide, a treatment for metastatic castration-resistant prostate cancer, was linked to a case of acute generalized exanthematous pustulosis (AGEP) in a 62-year-old male patient, indicating a potential skin-related side effect of this medication.
The patient's skin reaction occurred shortly after starting enzalutamide and resolved within four weeks, suggesting that the long half-life of enzalutamide (5.8 days) may contribute to the prolonged duration of symptoms.
Enzalutamide induced acute generalized exanthematous pustulosis.Alberto, C., Konstantinou, MP., Martinage, C., et al.[2020]
Enzalutamide (XTANDI) is an FDA-approved treatment for castration-resistant prostate cancer (CRPC) that effectively targets androgen receptor signaling, which is crucial for cancer progression.
In a Phase III clinical trial involving men with CRPC after chemotherapy, enzalutamide was well tolerated and significantly improved overall survival by 4.8 months, as indicated by reduced serum prostate-specific antigen (PSA) levels.
Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients.Dhingra, R., Sharma, T., Singh, S., et al.[2021]

References

Enzalutamide for patients with metastatic castration-resistant prostate cancer. [2020]
Enzalutamide induced acute generalized exanthematous pustulosis. [2020]
Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients. [2021]
Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. [2021]
Enzalutamide Bests Older NSAAs in mHSPC. [2021]
Enzalutamide-induced severe thrombocytopenia complicated by a seizure in a 76-year-old man with castration-resistant prostate cancer. [2022]
An update on enzalutamide in the treatment of prostate cancer. [2020]
Enzalutamide: a review of its use in chemotherapy-naïve metastatic castration-resistant prostate cancer. [2021]
Enzalutamide: A Review in Castration-Resistant Prostate Cancer. [2021]
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