Radiation + Hormone Therapy for Prostate Cancer
(SChLAP/IDC Trial)
Trial Summary
What is the purpose of this trial?
Prostate cancer (PCa) is the most frequently diagnosed cancer in men and second leading cause of cancer-related death. Men with PCa have a wide range of possible outcomes if the cancer has not spread and is classified as Intermediate-Risk PCa (IR-PCa). The standard treatment for IR-PCa is radiation therapy (RT) with or without hormone therapy which can result in cure in some men. In other men, the cancer can come back or spread to other areas of the body. Treatment response in men with IR-PCa is highly variable. This uncertainty has led to significant under- and over-treatment. This study aims to find out if the addition of intensive treatment (hormonal therapy: darolutamide + degarelix) to standard treatment for PCa will work better than standard treatment alone. To do this, some participants will receive hormone therapy and others will not. All participants will receive RT. Currently, it is difficult to identify men who may require more intensive therapy. Current methods, such as using prostate specific antigen (PSA) alone, may not give the doctor enough information about who requires more intensive treatment. The researchers conducting this study believe that a particular arrangement of cancer cells \[called intraductal carcinoma (IDC)\] and the presence of a genetic marker called SChLAP1 can be used to identify people who would benefit from more intensive therapy. Hormonal therapy such as with drugs called darolutamide (new drug for PCa) and Degarelix, reduce androgens (male hormones, such as testosterone) or block their effect on the cells. PCa cells require androgens to grow and divide, so removal of androgens may be effective in preventing the return of cancer following radiation therapy. Although darolutamide has been studied in about 1000 men with PCa and seems promising and well tolerated it is considered an experimental drug, therefore it can only be used in a research study such as this one. Degarelix has been approved by Health Canada to treat PCa. This is a phase 2, open label, randomized, controlled study and will be conducted across sites in Canada. To qualify, men must have IR-PCa and have both SChLAP1 and IDC present or both absent. Participants will be randomized to receive RT with hormone therapy or RT only. The study treatment period is 6 months for the RT + hormone therapy group. RT will take about 1-2 weeks. All participants will be followed for 5 years with multiple visits to assess safety and treatment effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken certain hormonal therapies or are on medications that might interact with the study drug. It's best to discuss your current medications with the study team to see if they might affect your eligibility.
What data supports the effectiveness of the treatment Radiation + Hormone Therapy for Prostate Cancer?
Research shows that radiotherapy, especially when combined with hormone therapy, is an effective treatment for prostate cancer. Techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) allow for higher doses with lower side effects, improving outcomes for patients.12345
Is the combination of radiation and hormone therapy safe for prostate cancer treatment?
Research shows that intensity-modulated radiotherapy (IMRT) combined with hormone therapy for prostate cancer is generally safe, with studies noting improvements in reducing side effects compared to older methods. Image-guided radiotherapy (IGRT) helps deliver precise doses, further minimizing toxicity (harmful side effects) and improving safety.678910
How is the combination of radiation and hormone therapy unique for treating prostate cancer?
The combination of radiation therapy and hormone therapy for prostate cancer is unique because it aims to enhance disease control and survival by preventing androgen (male hormone) stimulation of cancer cells, which is not achieved by radiation or hormone therapy alone. This approach can improve local control rates and is particularly beneficial for patients with localized prostate cancer, offering a balance between treatment efficacy and potential side effects.3471112
Research Team
Neil Fleshner, MD
Principal Investigator
UHN Princess Margaret Cancer Centre
Alejandro Berlin, MD
Principal Investigator
UHN Princess Margaret Cancer Centre
Eligibility Criteria
Men over 18 with Intermediate-Risk Prostate Cancer (IR-PCa) who have not spread to bones, are in good enough health to perform daily activities, and have specific cancer cell arrangements or genetic markers. They must not have had prior prostate cancer treatments that affect the whole body, severe anemia, low platelets, poor kidney or liver function, be on blood thinners, or used hormonal therapies within a year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive radiation therapy with or without hormone therapy (darolutamide + degarelix) for prostate cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Darolutamide
- Degarelix
- Radiation Therapy
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Bayer
Industry Sponsor
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
Prostate Cancer Canada
Collaborator