Hormone Therapy + Radiation for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: LHRH agonists, Antiandrogens, Estrogens, 5-alpha reductase inhibitors

Disqualifiers: Prior prostate surgery, Active lupus, AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

74 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if taking hormone pills can improve the quality of life and survival rates for patients who need hormone-based treatment. The pills work by adjusting hormone levels in the body to help manage their condition.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain hormonal therapies or medications like 5-alpha reductase inhibitors for prostate cancer, you may need to stop those before joining the trial.

What data supports the effectiveness of the drug Bicalutamide (Casodex) when used with radiation therapy for prostate cancer?

Research shows that adding Bicalutamide (Casodex) to radiation therapy significantly improves survival and reduces the risk of disease progression in men with locally advanced prostate cancer. ^{1 2 3 4 5}

Is hormone therapy with bicalutamide and radiation generally safe for humans?

Bicalutamide (Casodex) is generally well-tolerated in humans, with studies showing it is well-absorbed and has manageable side effects. When used with radiation therapy, it has been shown to improve survival in prostate cancer patients, and its side effects are considered manageable. ^{1 3 5 6 7}

How does the drug Bicalutamide combined with radiation differ from other prostate cancer treatments?

This treatment is unique because it combines Bicalutamide, a non-castration-based drug that blocks male hormones, with radiation therapy, which together significantly improve survival in men with locally advanced prostate cancer compared to radiation alone, without the severe side effects of traditional hormone therapies. ^{3 4 5 6 8}

Research Team

Stanley L. Liauw

Principal Investigator

University of Chicago

Eligibility Criteria

Men aged 18+ with intermediate or high-risk prostate cancer who haven't had radical surgery, hormonal therapy, or certain other treatments for prostate cancer. They should have a life expectancy of at least 10 years and be able to give informed consent. Men with severe health issues like unstable angina, active infections needing IV antibiotics, liver problems, AIDS, or autoimmune diseases are excluded.

Inclusion Criteria

Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%

One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4

Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal

Exclusion Criteria

Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer

Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy

Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hormonal Treatment

Participants receive oral hormonal therapy with bicalutamide and either dutasteride or finasteride

6 months

Questionnaires administered at 1-2 months and 3-4 months

Radiation Therapy

Participants undergo radiation therapy while continuing hormonal treatment

3-4 months

Questionnaires administered during RT

Follow-up

Participants are monitored for quality of life and biochemical failure

24 months

Questionnaires at 6, 12, 18, and 24 months after radiation

Long-term Follow-up

Participants are monitored for biochemical failure over a longer period

4 years

Treatment Details

Interventions

• Bicalutamide
• Dutasteride
• Finasteride
• Radiation

Trial Overview The trial is testing if oral hormone therapies (Bicalutamide, Dutasteride, Finasteride) plus radiation improve quality of life and survival rates compared to standard care in men with prostate cancer. It's looking at how well patients do on these drugs versus the usual treatment.

Participant Groups

Group I: Oral Androgen Therapy Experimental Treatment 4 Interventions

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

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

Approved in European Union as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in United States as Casodex for:

• Metastatic prostate cancer

Approved in Japan as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

In a study involving 3603 men with localized or locally advanced prostate cancer, bicalutamide significantly reduced the risk of disease progression by 43% compared to placebo after a median follow-up of 2.6 years.

Bicalutamide also delayed the time to prostate-specific antigen (PSA) doubling, indicating its efficacy in managing prostate cancer, although common side effects included gynecomastia and breast pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression. Wirth, M., Tyrrell, C., Wallace, M., et al.[2019]

Bicalutamide, when used in conjunction with radiation therapy, showed cytotoxic effects in androgen-dependent prostate cancer cells (LNCaP), leading to cell cycle arrest and reduced expression of prostate serum antigen (PSA) and androgen receptor (AR).

The study found that bicalutamide decreased the effectiveness of radiation in LNCaP cells, suggesting that it should not be administered close to radiation treatment to avoid antagonistic interactions, while showing an additive effect in androgen-independent DU145 cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antagonistic interaction between bicalutamide (Casodex) and radiation in androgen-positive prostate cancer LNCaP cells. Quéro, L., Giocanti, N., Hennequin, C., et al.[2014]

In a 7-year study involving patients with early, non-metastatic prostate cancer, adding bicalutamide (150 mg) to standard care significantly improved progression-free survival (PFS) for those with locally advanced disease, reducing the risk of progression by 34%.

However, in cases of localized disease, bicalutamide did not show a significant benefit in PFS, and there was no difference in overall survival between the treatment and standard care groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicalutamide (Casodex) 150 mg plus standard care in early non-metastatic prostate cancer: results from Early Prostate Cancer Trial 24 at a median 7 years' follow-up. Wirth, M., Tyrrell, C., Delaere, K., et al.[2014]

In a study of 1,370 patients with locally advanced prostate cancer, bicalutamide 150 mg combined with radiotherapy significantly improved progression-free survival (PFS) by 44% and overall survival by 35% compared to radiotherapy alone, indicating its efficacy as an adjuvant therapy.

Bicalutamide also showed a substantial reduction in the risk of prostate-specific antigen (PSA) progression by 59%, making it a promising non-castration-based treatment option that offers quality-of-life benefits over traditional castration therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The addition of bicalutamide 150 mg to radiotherapy significantly improves overall survival in men with locally advanced prostate cancer. See, WA., Tyrrell, CJ.[2018]

In a study of 51 patients undergoing treatment for prostate cancer with bicalutamide, localized radiotherapy improved gynaecomastia in about 26% and breast pain in about 32% of those treated, indicating some efficacy in managing these side effects.

The treatment was generally well-tolerated, with mild and short-lived adverse events reported in 44% of patients, suggesting that radiotherapy is a safe option for alleviating symptoms associated with bicalutamide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of radiotherapy as treatment for bicalutamide-induced gynaecomastia and breast pain in prostate cancer. Van Poppel, H., Tyrrell, CJ., Haustermans, K., et al.[2014]

Bicalutamide, particularly at a 150-mg daily dose, is effective as a monotherapy for locally advanced prostate cancer, providing similar survival outcomes to castration, while also improving quality of life.

When combined with a luteinizing hormone-releasing hormone agonist (LHRH-A), a lower 50-mg daily dose of bicalutamide shows equivalent efficacy to flutamide, with the added benefit of better tolerability and longer median survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicalutamide (Casodex) in the treatment of prostate cancer: history of clinical development. Kolvenbag, GJ., Blackledge, GR., Gotting-Smith, K.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Bicalutamide ('Casodex') 150 mg in addition to standard care in patients with nonmetastatic prostate cancer: updated results from a randomised double-blind phase III study (median follow-up 5.1 y) in the early prostate cancer programme. [2014]

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

Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression. [2019]

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

Antagonistic interaction between bicalutamide (Casodex) and radiation in androgen-positive prostate cancer LNCaP cells. [2014]

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

Bicalutamide (Casodex) 150 mg plus standard care in early non-metastatic prostate cancer: results from Early Prostate Cancer Trial 24 at a median 7 years' follow-up. [2014]

5. Germany pubmed.ncbi.nlm.nih.gov

The addition of bicalutamide 150 mg to radiotherapy significantly improves overall survival in men with locally advanced prostate cancer. [2018]

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

Efficacy and tolerability of radiotherapy as treatment for bicalutamide-induced gynaecomastia and breast pain in prostate cancer. [2014]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Casodex (bicalutamide): overview of a new antiandrogen developed for the treatment of prostate cancer. [2019]

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

Bicalutamide (Casodex) in the treatment of prostate cancer: history of clinical development. [2022]