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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if oral hormone therapy, combined with radiation, can improve quality of life and survival rates for prostate cancer patients compared to the usual treatment. Participants will take two oral hormonal drugs, Bicalutamide and either Dutasteride or Finasteride, and receive radiation to assess the effectiveness of this combination. Men diagnosed with prostate cancer who have specific risk factors, such as certain test results or tumor stages, might be suitable for this study. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance future prostate cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using bicalutamide with either dutasteride or finasteride is generally safe for patients. The FDA has approved bicalutamide for treating advanced prostate cancer, and it is usually well-tolerated. One study found that administering bicalutamide and dutasteride to patients in poor health was safe and manageable. Another study reported similar safety results when bicalutamide was combined with finasteride, indicating that the treatment is generally well-tolerated in different combinations. While any treatment carries risks, evidence suggests these drugs are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this combination treatment for prostate cancer because it pairs hormone therapy with radiation in a new way. Bicalutamide, a hormone therapy, is used with either dutasteride or finasteride, which could enhance its effectiveness. By combining these oral hormonal drugs with radiation, the treatment aims to more effectively reduce tumor growth compared to standard hormone therapy alone. This approach could offer more comprehensive control over cancer progression, potentially improving outcomes for patients.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will evaluate the effectiveness of combining bicalutamide with either dutasteride or finasteride as part of the oral androgen therapy arm. Research has shown that these combinations may help treat prostate cancer. Specifically, past studies linked this combination to a 65% survival rate over five years. These medications work together to lower prostate-specific antigen (PSA) levels, which can indicate prostate cancer activity. By blocking certain hormones, these drugs may enhance the treatment's effectiveness. Overall, this approach appears safe and practical, even for patients with other health issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Stanley L. Liauw

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2699636/

Role of 5 alpha-reductase inhibitors in the management ... Five year overall survival was 65% (Oh et al 2003). A similar phase II trial with biclutamide and finasteride produced comparable results. Thirty of 36 patients ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767324000740

5-Year Outcomes From a Trial Evaluating Combined ... The addition of finasteride to flutamide in a cohort of 20 patients was shown to reduce PSA further as compared to flutamide alone and maintain low to ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.122

Outcomes, frailty status, and body composition of men with ... Bicalutamide and dutasteride was generally safe and feasible in a cohort of HSPC with increased pre-treatment frailty and sarcopenia.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00470834

Prostate Cancer Study In Men Who Have Failed First-Line ... By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)61843-0/fulltext

Finasteride and bicalutamide as primary hormonal therapy ... This pilot study demonstrates that bicalutamide and finasteride may be given as primary hormonal therapy for advanced prostate cancer with few side-effects. In ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2950198925000327

Efficacy and safety of bicalutamide in female hair loss Bicalutamide, a peripherally selective antiandrogen, is FDA-approved for the treatment of metastatic prostate cancer and has recently demonstrated potential in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01200810

Bicalutamide and RO4929097 in Treating Patients With ... This partially randomized phase II trial is studying how well giving bicalutamide together with RO4929097 works in treating patients with previously treated ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7271889/

Prostate cancer patients can benefit from 5-alpha ... Results of meta-analysis revealed that 5ARI treatment significantly reduced the total progression of PCa (OR = 0.61, 95% CI [0.48–0.77], P < ...