None listed
Conditions
Brief summary
The purpose of this study is to test the idea of a new way of using an old drug in men with prostate cancer that has spread. Who is it for? You may be eligible for this study if you have advanced prostate cancer and are eligible to take a medicine called enzalutamide/Xtandi. Study details If a man taking enzalutamide chooses to take part in the study, their oncologist will advise them to pause taking their medication if their PSA blood test falls by over half. If their PSA blood test returns to pre-treatment levels, participants will then be advised to recommence taking the tablets again until again, the PSA blood test has decreased by more than 50%. The idea is to take breaks from the hormone tablets, using them for long enough to control the cancer, but then stopping and saving them up until later to treat the cancer again. The blood tests, scans, and doctors appointments in the trial are almost identical to normal treatments; men on the trial will be asked to complete short questionnaires, and have an extra blood test every three months. It is hoped this study will demonstrate this strategy of treatment will reduce side-effects, and may improve the lives and survival of men with prostate cancer.
Interventions
Men treated with standard dose enzalutamide (4 x 40mg capsules po OD) for CRPC will be registered, and will be enrolled and enter trial procedures if they experience 50% or more decline of their PSA (i.e. the likely rare patient that experiences primary resistance will not be eligible to continue). When the PSA blood test falls by more than 50%, enzalutamide will then be stopped. Ongoing monthly reviews and PSA blood tests we be attended. The participant will be advised to re-initiate enzalutami
Men treated with standard dose enzalutamide (4 x 40mg capsules po OD) for CRPC will be registered, and will be enrolled and enter trial procedures if they experience 50% or more decline of their PSA (i.e. the likely rare patient that experiences primary resistance will not be eligible to continue). When the PSA blood test falls by more than 50%, enzalutamide will then be stopped. Ongoing monthly reviews and PSA blood tests we be attended. The participant will be advised to re-initiate enzalutamide when the PSA level has reached the pre-treatment/baseline PSA level. E.g. if a man's PSA is 80 at the time of starting enzalutamide, falls below 40 and he paused enzalutamide treatment, then monthly visits and PSA blood tests will occur; when the man's blood test rises back to 80 or higher, he will be advised to restart the enzalutamide. This "loop" of patient-individualised precision adaptive therapy will be repeated for as long as there is ongoing patient consent, tolerance and safety (i.e. repeated re-response). Each time enzalutamide is stopped, it will be defined as the start of a new adaptive therapy cycle (a “loop”). This "loop" of patient-individualised precision adaptive therapy will be repeated indefinitely for as long as there is ongoing patient consent, tolerance and safety (i.e. repeated re-response). While the clinical trial will have a maximum of 24 months of follow-up for each participant, if the adaptive loops of therapy are continuing to control a participant's cancer after the end of follow-up for an individual participant, the participant and their clinician may choose to continue this strategy of dosing off-study.
Sponsors
Calvary Mater Newcastle
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
Participants are eligible to be included in the study only if all of the following criteria apply: · Histologically or biochemically confirmed adenocarcinoma of the prostate · Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or medical castration with testosterone at screening <0.5 ng/L) o Patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial; · Metastatic castration resistant prostate cancer (CRPC) · Prior treatment with taxane chemotherapy, (e.g. docetaxel and/or cabazitaxel) or predicted to be intolerant and not eligible for future chemotherapy · Controlled symptoms (opioids for cancer related pain stable for > 4 weeks, no need for urgent radiotherapy for symptomatic lesions) · Metastatic disease defined as at least 1 documented metastatic lesion on either a whole body bone scan or a CT scan of the chest, abdomen and pelvis. · Participant has chosen to take enzalutamide as standard of care treatment for CRPC
Exclusion criteria
· Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment; · Known or suspected brain metastasis or active leptomeningeal disease; · Any other therapies for CRPC (excluding denosumab) to be discontinued 3 weeks prior to study. · Prior treatments with CYP17 or androgen receptor inhibitors (abiraterone or enzalutamide prior to this course). Prior treatment with docetaxel or cabazitaxel is allowed. · Documented liver metastases
Outcome results
None listed