Flutamide for Prostate Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well the drug flutamide breaks down prostate cancer cells when combined with standard treatments like brachytherapy and hormone therapy. It compares flutamide to a placebo to determine any noticeable difference in treating prostate cancer. Men with prostate cancer who have a Gleason score of 7 or higher, indicating more aggressive cancer, and who plan to undergo brachytherapy might be suitable for this study. As an Early Phase 1 trial, this research aims to understand how flutamide works in people, offering participants a chance to contribute to groundbreaking cancer treatment research.

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 there any evidence suggesting that flutamide is likely to be safe for humans?

Research has shown that flutamide has been tested for safety in people with prostate cancer. In a large study involving 905 patients, researchers administered flutamide to individuals with advanced prostate cancer to assess safety and side effects.

However, another study found a high risk of side effects with flutamide. About 29.9% of participants experienced these side effects, and 12.8% discontinued treatment because of them. While flutamide can be effective, awareness of possible side effects is crucial when considering it as a treatment option.

For those considering joining a trial, understanding these risks is important. Always consult a doctor to determine the best course of action. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Flutamide is unique because it targets androgen receptors, which play a key role in the growth of prostate cancer cells, and has the potential to enhance the effectiveness of brachytherapy when used beforehand. While current treatments like androgen deprivation therapy and chemotherapy focus on reducing overall hormone levels, flutamide specifically blocks the action of testosterone on cancer cells. Researchers are excited about this approach because it could lead to more precise targeting of cancer cells, potentially improving outcomes and reducing side effects compared to traditional hormone therapies.

What evidence suggests that flutamide might be an effective treatment for prostate cancer?

Research has shown that flutamide, which participants in this trial may receive, effectively treats prostate cancer. In one study, 97% of patients taking flutamide did not experience cancer progression after two years, indicating stability during that period. Another study found that flutamide worked well as a primary hormonal treatment and had fewer serious side effects compared to other treatments. Although flutamide can cause side effects during treatment, it has improved survival rates in some prostate cancer patients. ^{1 3 5 6 7}

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38992964/

Efficacy and safety of androgen receptor inhibitors for ... Flutamide led to the highest risk of TEAEs (29.9%) and AEs leading to discontinuation (12.8%). Apalutamide (13.4%) led to the highest risk of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8708714/

Double-blind, randomized study of primary hormonal ... Conclusion: As the primary hormonal therapy for stage D2 prostate cancer, DES caused more serious cardiovascular or thromboembolic complications than flutamide.

3. cancernetwork.com cancernetwork.com/view/antiandrogen-improves-prostate-cancer-survival-stage-c-patients

Antiandrogen Improves Prostate Cancer Survival in Stage ... Progression-free survival rates in the flutamide group were 97% at twoyears and 90% at four years (relative risk of tumor progression, 0.34).Control group rates ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2001.19.1.62

Flutamide Versus Prednisone in Patients With Prostate ... RESULTS: There was no difference between the groups in median TTP (prednisone, 3.4 months; flutamide, 2.3 months) or overall survival (prednisone, 10.6 months; ...

5. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.16176

Efficacy and safety of androgen receptor inhibitors for ... The SUCRA concluded that the placebo showed the highest safety on the TEAEs outcome (91.8%), followed by bicalutamide (75.2%), enzalutamide ( ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00006214

Flutamide In the Prevention of Prostate Cancer in Patients ... Flutamide may be effective in the prevention of prostate cancer. PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8977067/

Tolerability and safety of flutamide in monotherapy, with ... Objective: In a multicenter study, 905 patients with newly diagnosed advanced prostate cancer treated with flutamide were followed for safety and side effects.