Flutamide for Prostate Cancer

Recruiting at 1 trial location

Overseen By Shirley DiPasquale, R.N.

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: Androgen suppression

Disqualifiers: Flutamide allergy, Severe hepatic impairment, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is flutamide safe for humans?

Flutamide has been studied for safety in prostate cancer patients, with some experiencing mild to moderate side effects. However, it can cause liver issues, especially in those with existing liver problems, and some patients have stopped treatment due to side effects. ^{1 2 3 4 5}

How does the drug flutamide differ from other treatments for prostate cancer?

Flutamide is a non-steroidal anti-androgen that works by blocking the action of male hormones (androgens) which can fuel the growth of prostate cancer. Unlike some other treatments, it can be used in combination with an LHRH agonist to enhance effectiveness, and it generally does not affect libido or sexual potency. ^{3 5 6 7 8}

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

Research shows that flutamide is effective in treating advanced prostate cancer, with response rates similar to traditional hormone therapy and improvements in symptoms and quality of life. Additionally, combining flutamide with other treatments like Zoladex can lead to quicker relief of symptoms, although it may also increase side effects. ^{3 5 7 9 10}

Who Is on the Research Team?

Daniel Song, M.D.

Principal Investigator

SKCCC at Johns Hopkins

Are You a Good Fit for This Trial?

Men with prostate cancer who've chosen brachytherapy and androgen suppression as treatments can join. They need to have a certain amount of detectable disease for biopsy, confirmed by tests, including at least one biopsy core with Gleason 7 or higher. Participants must sign a consent form. Those with severe liver issues, allergies to flutamide, or major illnesses that could affect treatment aren't eligible.

Inclusion Criteria

Signed study-specific consent form prior to registration

My prostate cancer diagnosis was confirmed through a tissue examination.

I have a tumor that can be felt and biopsied.

Exclusion Criteria

Known hypersensitivity or allergic response to flutamide

I have severe liver problems.

Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Initial 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention with 50mg flutamide prior to brachytherapy and prostatic biopsy

Duration not specified

Randomized Treatment

Randomized, double-blind phase with patients receiving either 50mg flutamide or placebo prior to brachytherapy and prostatic biopsy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flutamide

Trial Overview The study is testing if a single dose of the drug flutamide can cause double strand breaks in DNA within prostate cancer cells during standard treatment. It's compared against a placebo in men already receiving hormone therapy and brachytherapy.

How Is the Trial Designed?

Group I: flutamide Experimental Treatment 1 Intervention

50mg flutamide prior to brachytherapy and prostatic biopsy

Group II: placebo Placebo Group 1 Intervention

placebo prior to brachytherapy and prostatic biopsy

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

Approved in United States as Eulexin for:

• Prostate cancer

Approved in European Union as Flutamide for:

• Prostate cancer

Approved in Canada as Flutamide for:

• Prostate cancer

Approved in Japan as Flutamide for:

• Prostate cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Patrick C. Walsh Fund

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study involving 304 patients with advanced prostate cancer, there was no significant difference in overall and progression-free survival between those treated with Zoladex alone and those treated with Zoladex plus flutamide.

The combination treatment of Zoladex and flutamide resulted in a higher response rate and quicker relief of bone pain, but it also led to more side effects, suggesting that the combination may not provide a clear advantage over Zoladex alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP). Boccardo, F., Decensi, A., Guarneri, D., et al.[2019]

In a study of 905 patients with advanced prostate cancer, flutamide was found to be safe and well tolerated, with only 2% of patients withdrawing due to severe diarrhea and 0.8% due to liver function changes.

The most common side effects included gastrointestinal issues (around 15% incidence) and hot flushes (40% in total androgen blockade groups), but no unexpected dangerous adverse events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and safety of flutamide in monotherapy, with orchiectomy or with LHRH-a in advanced prostate cancer patients. A Belgian multicenter study of 905 patients. Oosterlinck, W., Casselman, J., Mattelaer, J., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of in vitro effects of the pure antiandrogens OH-flutamide, Casodex, and nilutamide on androgen-sensitive parameters. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Is there a role for pure antiandrogens in the treatment of advanced prostatic cancer? [2014]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP). [2019]

4. England pubmed.ncbi.nlm.nih.gov

Predictors of poor response to secondary alternative antiandrogen therapy with flutamide in metastatic castration-resistant prostate cancer. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Adrenal androgen levels as predictors of outcome in castration-resistant prostate cancer patients treated with combined androgen blockade using flutamide as a second-line anti-androgen. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Tolerability and safety of flutamide in monotherapy, with orchiectomy or with LHRH-a in advanced prostate cancer patients. A Belgian multicenter study of 905 patients. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Characteristics of adverse drug reactions induced by flutamide and bicalutamide: a real-world pharmacovigilance study using FAERS. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Flutamide as primary treatment for metastatic prostatic cancer. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A rationale for the use of non-steroidal anti-androgens in the management of prostate cancer. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Prospective randomized trial comparing flutamide as adjuvant treatment versus observation after radical prostatectomy for locally advanced, lymph node-negative prostate cancer. [2022]