Radiation + Hormone Therapy for Prostate Cancer

(SChLAP/IDC Trial)

Overseen By Sunakshi Chowdhary

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must not be taking: Hormonal therapy, Cytotoxic therapy

Disqualifiers: Cardiac events, Anticoagulant therapy, 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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding hormone therapy to standard radiation treatment can better manage prostate cancer that hasn't spread but is difficult to predict. It uses two drugs, darolutamide and degarelix, which aim to reduce male hormones that promote cancer growth. The trial includes men with prostate cancer who have specific cancer cell patterns or genetic markers. Participants will receive either radiation therapy alone or with the added hormone treatment. The goal is to determine if this combination can more effectively reduce the cancer's return or spread. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Studies have shown that darolutamide is generally well-tolerated for treating prostate cancer. Research involving about 1,000 men found that most experienced positive outcomes, such as improved quality of life and reduced prostate-specific antigen levels, which indicate cancer activity. Although researchers continue to study darolutamide, it has shown promise and has been used in similar prostate cancer treatments.

Degarelix is already approved in Canada for treating prostate cancer, indicating it has been tested and found safe for this use.

This study tests a combination of darolutamide, degarelix, and radiation therapy. While researchers continue to investigate darolutamide, previous studies suggest it is well-tolerated. The approval of degarelix adds an additional level of safety to the treatment. ^{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 combine radiation therapy with two promising drugs: darolutamide and degarelix. While radiation therapy is a standard treatment for prostate cancer, darolutamide is a newer androgen receptor inhibitor that blocks male hormones from fueling cancer growth. Degarelix, on the other hand, is a hormone therapy that quickly lowers testosterone levels, which can help shrink tumors. By using these drugs alongside radiation, the hope is to enhance the effectiveness of treatment and potentially improve outcomes for patients.

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

This trial will compare two treatment approaches for prostate cancer. Group 1 will receive radiation therapy only, while Group 2 will receive a combination of radiation therapy, darolutamide, and degarelix. Research has shown that combining darolutamide and degarelix with radiation therapy might enhance prostate cancer treatment. Studies have found that darolutamide, when used with other treatments, can extend the lives of prostate cancer patients. Degarelix, already approved for treating prostate cancer, works by lowering male hormones that cancer cells need to grow. Patients who used darolutamide reported better outcomes, including lower levels of prostate-specific antigen (PSA), which indicates better cancer control. Although darolutamide is still under study for some uses, it has shown promise in treating prostate cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Neil Fleshner, MD

Principal Investigator

UHN Princess Margaret Cancer Centre

Alejandro Berlin, MD

Principal Investigator

UHN Princess Margaret Cancer Centre

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Darolutamide
• Degarelix
• Radiation Therapy

Trial Overview The 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.

How Is the Trial Designed?

Group I: Group 2: Radiation Therapy + darolutamide + degarelix Experimental Treatment 3 Interventions

Participants randomized to Group 2 will receive radiation therapy only + darolutamide + degarelix.

Group II: Group 1: Radiation Therapy Only Active Control 1 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

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

Bayer

Chief Medical Officer since 2014

MD, PhD

Prostate Cancer Canada

Collaborator

Trials

10

Recruited

7,500+

Published Research Related to This Trial

Radiotherapy can be an effective curative treatment for prostate cancer, especially when patient selection is done carefully to maximize benefits.

Dose-escalated radiation and advanced imaging technologies have improved patient outcomes, and there is renewed interest in hypofractionated radiotherapy methods like stereotactic body radiotherapy and brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary issues in radiotherapy for clinically localized prostate cancer. Khor, R., Williams, S.[2013]

Patients with high-risk prostate cancer treated with image-guided intensity-modulated radiotherapy (IG-IMRT) experienced significantly lower rates of gastrointestinal (GI) toxicity (5.8%) compared to those treated with 3D conformal radiotherapy (3DCRT) (57.3%), indicating that IG-IMRT is a safer option.

Both IG-IMRT and 3DCRT showed similar rates of biochemical progression-free survival at 3 years (90.3% for IG-IMRT vs. 86.0% for 3DCRT), suggesting that while IG-IMRT reduces toxicity, it does not compromise treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sveistrup, J., af Rosenschöld, PM., Deasy, JO., et al.[2021]

In a study of 192 patients with localized prostate cancer, using prostate-based IGRT (P-IGRT) resulted in significantly lower acute gastrointestinal toxicities compared to bony structure-based IGRT (B-IGRT), with rates of 3% versus 11%.

Both P-IGRT and B-IGRT showed similar prostate-specific antigen failure-free survival rates at 3 years (95.5% for P-IGRT and 92.7% for B-IGRT), indicating that P-IGRT can reduce toxicity without compromising tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

In a study of 100 prostate cancer patients treated with high-dose intensity-modulated radiotherapy (IMRT) and image-guided treatment (IGRT), acute gastrointestinal (GI) toxicity was observed in 12% and genitourinary (GU) toxicity in 42%, with only 4% experiencing severe GU toxicity (grade 3).

After a median follow-up of 26 months, late toxicity rates were low, with only 1.5% experiencing late GI toxicity and 7.7% experiencing late GU toxicity, indicating that high-dose radiotherapy is both effective and has manageable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. Guckenberger, M., Ok, S., Polat, B., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What is the level of evidence of new techniques in prostate cancer radiotherapy?]. Khadige, M., Peiffert, D., Supiot, S.[2018]

Intensity-modulated radiotherapy (IMRT) combined with image-guided radiotherapy (IGRT) is recommended for high-dose treatments (≥76Gy) in prostate cancer, as it allows for effective dose escalation while managing toxicity.

Stereotactic body radiotherapy shows promise for prostate cancer treatment, but more extensive follow-up and phase III trials are needed to establish its efficacy and safety compared to established techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. de Crevoisier, R., Castelli, J., Guérif, S., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensified autophagy compromises the efficacy of radiotherapy against prostate cancer. Koukourakis, MI., Kalamida, D., Mitrakas, A., et al.[2022]

Radiotherapy is as effective as radical prostatectomy for localized prostate cancer when administered at sufficient doses, with various modalities like interstitial brachytherapy and external beam radiotherapy available.

Advancements such as intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) allow for higher radiation doses while reducing toxicity, and combining radiotherapy with hormonal ablation enhances local control rates in specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy in prostate cancer]. Ganswindt, U., Belka, C.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04176081

NCT04176081 | Study of Radiation Therapy in ... Hormonal therapy such as with drugs called darolutamide (new drug for PCa) and Degarelix, reduce androgens (male hormones, such as testosterone) or block their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705205/

Review of Current Treatment Intensification Strategies for ... This review summarizes the radiotherapy-centered therapeutic combinations and trials that have been tested for the treatment of localized PCa

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2022/darolutamide-survival-metastatic-prostate-cancer

Darolutamide Extends Survival in Metastatic Prostate Cancer Adding darolutamide (Nubeqa) to ADT and docetaxel improves survival in hormone-sensitive metastatic prostate cancer, results from the ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK596333/

Pharmacoeconomic Review - Darolutamide (Nubeqa) - NCBI Most patients with experience on darolutamide reported improved outcomes in terms of prostate-specific antigen and quality of life, and stated that the benefits ...

5. bayer2019tf.q4web.com bayer2019tf.q4web.com/news/news-details/2025/U-S--FDA-Approves-NUBEQA-darolutamide-to-Treat-Patients-with-Metastatic-Castration-Sensitive-Prostate-Cancer/default.aspx

U.S. FDA Approves NUBEQA® (darolutamide) to Treat ... The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/212099Orig1s000MultidisciplineR.pdf

Multi-Discipline Review - accessdata.fda.gov NUBEQA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

7. bayer2019tf.q4web.com bayer2019tf.q4web.com/news/news-details/2025/New-Data-for-NUBEQA-Build-on-Safety-and-Efficacy-Results-Across-Subgroups-of-Patients-with-Metastatic-Hormone-Sensitive-Prostate-Cancer/default.aspx

New Data for NUBEQA® Build on Safety and Efficacy Results ... New subgroup data from the investigational Phase III ARANOTE trial show NUBEQA (darolutamide) plus androgen-deprivation therapy (ADT) improved radiological ...