Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Launched by TRANS TASMAN RADIATION ONCOLOGY GROUP · Mar 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the combination of a drug called darolutamide and a type of treatment known as consolidation radiotherapy for men with advanced prostate cancer. Specifically, it focuses on patients whose cancer is resistant to hormone therapy and can be detected using a special imaging technique called PSMA PET. The goal is to see if this combination can improve outcomes for these patients, particularly since darolutamide has already shown benefits for a similar group of patients using standard imaging methods.

To be eligible for this trial, participants must be adult men aged 18 or older with confirmed advanced prostate cancer that is no longer responding to hormone treatment. They should have a specific level of prostate-specific antigen (PSA) in their blood and evidence of cancer in certain areas based on PSMA PET scans. Participants will receive the study treatment and will be closely monitored for their health and any side effects. It’s important to note that some individuals, such as those with certain health conditions or who have had specific treatments recently, may not qualify for the trial. Overall, this study aims to explore a new approach to treating advanced prostate cancer and could potentially lead to better treatment options in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • ≥ 18 years of age and provided written Informed Consent
• • Histologically or cytologically confirmed adenocarcinoma 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 hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy
• • A baseline PSA level of at least 1ng per millilitre and a PSA doubling time of 10 months or less
• • Adequate bone marrow reserve and organ function Eastern Cooperative Oncology 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 recurrence within the prostate gland or prostate bed
• • Regional lymph node disease (below the aortic bifurcation)
• • Extra-pelvic lymph node, bone or soft tissue metastatic disease
• Exclusion Criteria:
• • Patients with detectable metastases or a history of metastatic disease on conventional imaging
• • Prior treatment with second-generation androgen receptor (AR) antagonists, CYP17 enzyme inhibitors or oral ketoconazole
• • Use of oestrogens or 5-α reductase inhibitors or anti-androgens within 28 days before randomisation
• • Use of systemic corticosteroid with a dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomisation
• • Radiotherapy within 12 weeks prior to randomisation
• • Initiation of treatment with an osteoclast-targeted therapy to prevent skeletal-related events within 12 weeks before randomisation
• • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV
• • Uncontrolled hypertension
• • Prior malignancy
• • Gastrointestinal disorder or procedure that expects to interfere significantly with the absorption of study treatment
• • Unable to swallow study medications and comply with study requirements