Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Prostatic Neoplasms

Carcinoma, Intraductal, Noninfiltrating

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Dilated Cardiomyopathy 1A

Participants randomized to Group 1 will receive radiation therapy only.

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

Darolutamide will be administered orally as a tablet. Total daily dose is 1200 mg (2 tablets of 300 mg taken twice daily) for 6 months.

Darolutamide

Degarelix is administered by subcutaneous injection. The first dose of degarelix is 240 mg followed by monthly doses of 80 mg for a total treatment duration of 6 months.

Degarelix

The total radiotherapy dose for all subjects will be: 36.25 Gy in 5Fx. The study will not include elective nodal irradiation. Every fraction will have 3D image guidance (i.e. cone-beam CT).

Radiation Therapy

Sunakshi Chowdhary

Neil Fleshner, MD

Alejandro Berlin, MD

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.

Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

A Prospective, Randomized, Open-label, Multi-centre, Phase II Trial Evaluating IDC/SChLAP1 as a Biomarker for Prediction of Response to Intensified Combined Modality Treatment

To determine the safety of ST-2gen-ADT combined with SABR compared to SABR alone.

To determine the tolerability of ST-2gen-ADT combined with SABR compared to SABR alone by determining the number of subjects discontinuing investigational products due to Adverse Events

Recurrence Free Survival (RFS), with recurrence event defined as (whichever occurs first):

* Biochemical failure defined as per Phoenix criteria (i.e., a rise in PSA by 2 ng/mL or more above the nadir PSA, confirmed by a second PSA measurement)
* Clinical, radiographic, or pathological evidence of local, regional, or distant recurrence/metastasis
* Initiation of salvage hormonal therapy
* Death from any cause.

To prospectively assess the role of IDC/SChLAP1 in UIR-PCa treated with curative intent radiation to predict those who derive the greatest benefit from ST-2gen-ADT.

To determine the impact of ADT hormone therapy combined with radiation therapy compared to radiation therapy alone in improving rates of early failures.

To assess the patterns of failure after ST-2gen-ADT combined with SABR compared to SABR alone.

To determine the effect of ST-2gen-ADT combined with SABR compared to SABR alone on the duration of castrate testosterone levels (\<50 ng/dL) after treatment completion.

To determine the effect of ST-2gen-ADT combined with SABR compared to SABR alone on Health Related Quality of Life (HRQOL).

To determine the effect of ST-2gen-ADT combined with SABR compared to SABR alone on PSA levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer	NCT04176081	Prostate Cancer	Darolutamide Degarelix Radiation Thera...	18 Years -	University Health Network, Toronto
Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer	NCT04176081	Prostate Cancer	Darolutamide Degarelix Radiation Thera...	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for intraductal carcinoma