208 Participants Needed

Radiation + Hormone Therapy for Prostate Cancer

(SChLAP/IDC Trial)

MK
SC
Overseen BySunakshi Chowdhary
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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 – Division of Urology ...

Neil Fleshner, MD

Principal Investigator

UHN Princess Margaret Cancer Centre

AB

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

My prostate cancer is intermediate-risk with specific PSA levels, Gleason score, or tumor size.
Able and willing to provide signed informed consent as per International Conference on Harmonization - Good Clinical Practices Guidelines (ICH-GCP) and applicable regulations.
My recent scans show no cancer spread to pelvic lymph nodes.
See 6 more

Exclusion Criteria

Participation in another interventional clinical trial during and / or within 3 months of consent for this study
Serum albumin < 3.0 g/dL within 90 days prior to consent
I have not had recent heart problems like unstable angina, heart attacks, or heart failure.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy with or without hormone therapy (darolutamide + degarelix) for prostate cancer

6 months
Weekly visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Multiple visits to assess safety and treatment effects

Treatment Details

Interventions

  • Darolutamide
  • Degarelix
  • Radiation Therapy
Trial OverviewThe study is testing if adding hormone therapy (Darolutamide and Degarelix) to standard radiation treatment improves outcomes for men with IR-PCa. Participants will either receive both treatments or just radiation in this phase 2 trial conducted across Canada. The treatment period lasts six months followed by five years of monitoring.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: Radiation Therapy + darolutamide + degarelixExperimental Treatment3 Interventions
Participants randomized to Group 2 will receive radiation therapy only + darolutamide + degarelix.
Group II: Group 1: Radiation Therapy OnlyActive Control1 Intervention
Participants randomized to Group 1 will receive radiation therapy only.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇺🇸
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇯🇵
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇳
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
🇨🇭
Approved in Switzerland as Radiation Therapy for:
  • 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

Trials
1,555
Recruited
526,000+

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 profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Prostate Cancer Canada

Collaborator

Trials
10
Recruited
7,500+

Findings from Research

A systematic review of 40 studies found that combining external beam radiotherapy (EBRT) with high-dose rate (HDR) brachytherapy (EBTI) provides superior biochemical control and overall survival for prostate cancer patients.
Specifically, the risk of biochemical recurrence and overall survival was significantly better with EBTI compared to EBRT and EBSeeds, with hazard ratios indicating a 40% and 50% increased risk of recurrence and mortality, respectively, for EBRT compared to EBTI.
Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review.Pieters, BR., de Back, DZ., Koning, CC., et al.[2018]
Prostate cancer cells exhibit high levels of autophagy, indicated by high LC3A and low LAMP2a levels, which are associated with poorer outcomes in patients treated with radical radiotherapy.
Blocking components of the autophagy pathway can increase the sensitivity of prostate cancer cells to radiation, suggesting that targeting autophagy may enhance the effectiveness of radiotherapy in high-risk patients.
Intensified autophagy compromises the efficacy of radiotherapy against prostate cancer.Koukourakis, MI., Kalamida, D., Mitrakas, A., et al.[2022]
Prostate cancer treatment has advanced significantly from traditional 2D radiotherapy to more precise methods like intensity-modulated radiation therapy (IMRT) and stereotactic radiotherapy, enhancing treatment efficacy and reducing side effects.
Emerging techniques such as proton therapy and carbon therapy are being explored to further improve treatment outcomes, shorten treatment times, and minimize toxicity and costs for patients.
[What is the level of evidence of new techniques in prostate cancer radiotherapy?].Khadige, M., Peiffert, D., Supiot, S.[2018]

References

Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. [2018]
Intensified autophagy compromises the efficacy of radiotherapy against prostate cancer. [2022]
[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. [2018]
[Radiotherapy in prostate cancer]. [2021]
Contemporary issues in radiotherapy for clinically localized prostate cancer. [2013]
Intensity-modulated radiotherapy combined with endocrine therapy for intermediate and advanced prostate cancer: long-term outcome of Chinese patients. [2019]
[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. [2018]
Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]
Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance. [2021]
Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. [2022]
Hormone and radiotherapy versus hormone or radiotherapy alone for non-metastatic prostate cancer: a systematic review with meta-analyses. [2022]
[Prostate cancer 2010. Therapeutic innovations]. [2011]