Hormone Therapy + Radiation for Prostate Cancer

Not currently recruiting at 13 trial locations

Overseen By Grace Pratt

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: AR inhibitors, Estrogens

Disqualifiers: Prior prostate cancer treatment, Metastatic disease, Severe heart conditions, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new hormone therapy combined with radiation to treat intermediate-risk prostate cancer. The researchers aim to determine if it works as well as current treatments but with fewer side effects on erectile function. Participants will receive either the experimental drug Darolutamide (a hormone therapy) or a standard hormone therapy combined with radiation. The study seeks men diagnosed with intermediate-risk prostate cancer who have good erectile function and can undergo radiation therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have used certain hormonal therapies or medications like testosterone injections or 5-α reductase inhibitors recently. It's best to discuss your specific medications with the trial team.

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

Research has shown that darolutamide is generally well-tolerated. In one study, most patients did not experience a significant decline in physical abilities after 24 weeks of treatment. Although a few cases of blood flow-related issues occurred, they were rare and affected only a small number of patients.

For bicalutamide combined with a GnRH agonist, studies indicate a positive safety profile. In one study, patients had a high survival rate over five years, with no major safety concerns reported. Another study found that overall survival was slightly better in the bicalutamide group compared to a placebo group.

Both treatments appear safe based on current evidence, but individual experiences can vary. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they offer new combinations that might enhance effectiveness. Darolutamide, when paired with radiation therapy, is noteworthy because it can potentially improve outcomes by specifically targeting cancer cells with a different mechanism of action than traditional androgen deprivation therapies. On the other hand, the combination of Bicalutamide with a GnRH agonist and radiation therapy could optimize hormone therapy effects by blocking and reducing testosterone. These approaches are designed to improve upon current standard treatments, which typically involve hormone therapy and radiation separately, by potentially increasing the precision and effectiveness of the treatment while maintaining a manageable side effect profile.

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

In this trial, participants will receive either Darolutamide or Bicalutamide as part of their treatment regimen. Research has shown that Darolutamide, when combined with hormone therapy (ADT), significantly extends the time prostate cancer patients live without disease progression, as observed in scans. One study found it reduced the risk of cancer progression by 40%. This makes Darolutamide a strong option for managing prostate cancer alongside radiation treatment.

Similarly, Bicalutamide, when used with GnRH agonists, has been shown to reduce the risk of disease progression by 42% compared to standard care alone. It also improves the quality of life for patients with advanced prostate cancer. Both treatments in this trial offer promising ways to effectively manage prostate cancer symptoms and slow its progression. ^{6 7 8 9 10}

Who Is on the Research Team?

Martin T. King, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

Men over 18 with intermediate risk prostate cancer (T2b-T2c, Gleason 7, PSA 10-20 ng/mL) who have good erectile function and can swallow pills. They must not have had certain previous treatments for prostate cancer or other conditions that overlap with the trial's treatment areas. Participants need to agree to use contraception and should be able to undergo radiation therapy.

Inclusion Criteria

My prostate cancer is at an intermediate stage, with specific test results.

PSA 10-20 ng/mL

My prostate cancer has a Gleason score of 7.

Exclusion Criteria

I have been treated with specific prostate cancer drugs for more than 28 days.

Any condition that, in the opinion of the site investigator, would preclude participation in this study

I have undergone orchiectomy or been on hormonal therapy for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Darolutamide or Bicalutamide with GnRH Agonist and Radiation Therapy

4-16 weeks

Regular visits for radiation therapy administration

Follow-up

Participants are monitored for safety, effectiveness, and erectile function after treatment

3 years

Annual visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Bicalutamide
• Darolutamide
• GnRH Agonist
• Radiation Therapy

Trial Overview The study is testing a new hormonal therapy combined with radiation against standard hormone therapy in treating intermediate risk prostate cancer. The goal is to see if the new therapy works as well while better preserving erectile function.

How Is the Trial Designed?

Group I: Darolutamide+Radiation Therapy Experimental Treatment 2 Interventions

* Darolutamide is administered orally twice daily * Radiation therapy is administered starting 4-16 weeks after Darolutamide

Group II: Bicalutamide+GnRH Agonist+Radiation Therapy Experimental Treatment 3 Interventions

* Bicalutamide is administered orally on a daily basis * GnRH Agonist as prescribed * Radiation therapy is administered starting 4-16 weeks after ADT

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

Approved in United States as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Approved in European Union as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Approved in Canada as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Decipher Biosciences

Collaborator

Trials

2

Recruited

5,200+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9606617/

Bicalutamide in advanced prostate cancer. A review Rate of treatment failure, the primary end-point, was significantly lower at 49 weeks with bicalutamide in this study, mainly because of a lower rate of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569905602000830

Results from the Bicalutamide ('Casodex') EPC Programme Bicalutamide 150 mg significantly reduced the risk of objective progression by 42% (p⪡0.0001) compared with standard care alone. This effect was seen in ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2004.22.90140.4703

Addition of bicalutamide 80 mg to LHRH-agonist ... Bicalutamide 80 mg in combination with an LHRH agonist improves symptom-related QoL in pts with previously untreated advanced prostate cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6133134/

Patterns of Bicalutamide Use in Prostate Cancer Treatment A 2007 RCT study by Akaza et al. showed that bicalutamide 80 mg offered a significant overall survival benefit compared with LHRH-agonist ...

5. journals.lww.com journals.lww.com/indianjcancer/fulltext/2022/59001/gonadotropin_releasing_hormone_agonists_in.12.aspx

Gonadotropin-releasing hormone agonists in prostate cancer When either goserelin or leuprolide was used, the 10-year OS rate was 62%. As an adjuvant to radical prostatectomy, goserelin had a 10-year survival rate of 87% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9119688/

Nonrandomized Comparison of Efficacy and Side Effects of ... In the salvage radiation therapy setting, bicalutamide has been shown to reduce overall mortality.

7. ar.iiarjournals.org ar.iiarjournals.org/content/39/11/6373

Radiotherapy Plus GnRH Analogue Versus High Dose ... Five-year biochemical relapse-free survival was 85.5% and 88.3% in patients treated with GnRHa and bicalutamide, respectively (p=0.712). Conclusion: ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1607529

Radiation with or without Antiandrogen Therapy in ... The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS5126

A phase 1 safety and feasibility study of intratumoral ... A phase 1 safety and feasibility study of intratumoral placement of bicalutamide implants combined with radiotherapy for localized prostate ...

10. urotoday.com urotoday.com/video-lectures/genomic-classifier-in-prostate-cancer-post-radical-prostatectomy/video/1552-data-from-the-rtog-studies-dan-spratt.html

Treating Prostate Cancer Patients with Low-Volume Disease Overall, the study was published two years ago and showed a survival benefit for the addition of hormone therapy, bicalutamide. But we took a second look into ...