None listed
Conditions
Brief summary
This is a study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer. Who is it for? You may be eligible for this study if you are an adult male with castrate resistant prostate cancer, with no evidence of metastatic disease (M0) on conventional imaging [Whole Body Bone Scan (WBBS) and Computed Tomography (CT) scan at screening] and prostate specific antigen (PSA) only progression on darolutamide. Study details Study participants will receive cyclical treatment with intramuscular (IM) testosterone, darolutamide and ongoing medical/surgical castration. This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression. Participants will be asked to provide blood samples, complete questionnaires and undergo scans during their treatment. It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer.
Interventions
The intervention is bipolar androgen therapy (BAT) which will be delivered in 56-day cycles. This involves an intramuscular injection of testosterone enanthate 500mg on day 1 of each 56-day cycle and darolutamide 600mg, orally, twice per day on days 29-56 of each 56-day cycle. Participants will have concomitant castration throughout via Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist. The LHRH agonist/antagonist used will be as per standard of care treatment that participants wer
The intervention is bipolar androgen therapy (BAT) which will be delivered in 56-day cycles. This involves an intramuscular injection of testosterone enanthate 500mg on day 1 of each 56-day cycle and darolutamide 600mg, orally, twice per day on days 29-56 of each 56-day cycle. Participants will have concomitant castration throughout via Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist. The LHRH agonist/antagonist used will be as per standard of care treatment that participants were receiving prior to enrolling in the study. Participants will continue their treatment until evidence of metastatic disease on conventional imaging unless treated beyond progression. Formal drug accountability will not be performed during the study, however, will be estimated from a narrative review with each participant at appropriate clinic visits where treatment adherence will be assessed.
The intervention is bipolar androgen therapy (BAT) which will be delivered in 56-day cycles. This involves an intramuscular injection of testosterone enanthate 500mg on day 1 of each 56-day cycle and darolutamide 600mg, orally, twice per day on days 29-55 of each 56-day cycle. Participants will have concomitant castration throughout via Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist. The LHRH agonist/antagonist used will be as per standard of care treatment that participants wer
The intervention is bipolar androgen therapy (BAT) which will be delivered in 56-day cycles. This involves an intramuscular injection of testosterone enanthate 500mg on day 1 of each 56-day cycle and darolutamide 600mg, orally, twice per day on days 29-55 of each 56-day cycle. Participants will have concomitant castration throughout via Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist. The LHRH agonist/antagonist used will be as per standard of care treatment that participants were receiving prior to enrolling in the study. Participants will continue their treatment until evidence of metastatic disease on conventional imaging unless treated beyond progression. Formal drug accountability will not be performed during the study, however, will be estimated from a narrative review with each participant at appropriate clinic visits where treatment adherence will be assessed.
Sponsors
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed adenocarcinoma of the prostate 2. >=18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. PSA progression while on darolutamide defined as three rising PSA (1 baseline and 2 consecutive rises) levels at least 1 week apart despite castrate testosterone level (18 months of ADT + darolutamide are eligible. b. Nodes up to 2cm in short-axis in pelvis are permitted 6. PSA >1.0 ng/mL during screening 7. Serum testosterone <1.7nmol/L and on an LHRH agonist/antagonist 8. Adequate bone marrow function 9. Adequate liver function 10. Adequate renal function 11. Willingness and ability to comply with study requirements, including treatment and timing of treatment.
Exclusion criteria
1. Life expectancy 160 or diastolic BP>100 despite optimal treatment) that are uncontrolled, as assessed by the treating oncologist. 6. Another malignancy diagnosis within 2 years before registration. Participants with a history of treated carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or non-muscle invasive urothelial carcinoma of the bladder are eligible if malignancy has been treated with curative intent. Participants with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment or the chance of recurrence is sufficiently low as to be very unlikely to affect study outcomes according to the treating local oncologist. 7. Concurrent illness that could preclude the participant’s ability to participate in the study and follow protocol with reasonable safety. 8. Planned ongoing drug Interactions that are considered unable to be managed prior to study registration. 9. Radiation therapy within the previous 4 weeks (participants are permitted to have Stereotactic body radiotherapy (SBRT) to PSMA PET only disease prior to study enrolment if they continue on darolutamide. Note that if the metastases are visible on conventional imaging at the time of radiation treatment the participant is not eligible).
Outcome results
None listed