Brief Summary
Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs when using conventional imagingtests that create detailed images of areas inside the body. However, it is estimated that >90% of patients have disease apparent when using PSMA PET. This study investigates the use of local consolidation radiotherapy in this cohort of men.
Intervention / Treatment
- Drug: Darolutamide
- Radiation: Radiotherapy
Inclusion Criteria
- ≥ 18 years of age and provided written Informed Consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- Histologically or cytologically confirmed adenocarcinomacancer arising from mucus-producing glands in organs of the prostate without neuroendocrine differentiation or small cell features
- Castration-resistant prostate cancer, defined as at least 2 consecutive PSA rises obtained at least 1 week apart in the setting of castrate testosterone levels
- Castrate level of serum testosterone (<1.7 nmol/l [50 ng/dl]) on gonadotrophin – releasing hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body (GnRH) agonist or antagonist therapy or after bilateralaffecting both sides orchiectomyremoval of one or both testicles, also known as orchidectomy
- A baseline PSA level of at least 1ng per millilitre and a PSA doubling time of 10 months or less
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells reserve and organ function Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions; At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions:
- Local recurrenceto occur or happen again within the prostate gland or prostate bed
- Regional lymph nodea small lump or mass of tissue in your body disease (below the aortic bifurcation)
- Extra-pelvic lymph node, bone or soft tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints metastatic disease