Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
The Clatterbridge Cancer Centre NHS Foundation Trust
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
\- Male 18 years of age or older
Diagnosis of metastatic adenocarcinoma of the prostate (either histologically confirmed or PSA \>100 and multiple bone metastasis and or abnormal MRI prostate compatible with metastatic prostate cancer)
Previous radical prostatectomy or radical radiotherapy is allowed
Bisphosphonate therapy (any type) is allowed but needs to be continued throughout the time on study
Bicalutamide, aLHRH (any type) or LHRH (any type) should be continued throughout the study period.
Any medication to treat medical conditions (for example hypertension) at enrolment are allowed and should be continued. These should be recorded on the CRF.
If the patient takes any complementary therapies (for example cannabis oil), potential risks and drug interactions should be discussed with the patient. If the patient decides to continue with the medication, they should be recorded on the CRF.
Group 1-3:
Metastatic (M1) hormone sensitive prostate cancer (conventional or PSMA PET or MRI imaging).
Any pelvic lymph nodes (N0 - N1) and any local disease stage (T1-T4)
Group 1:
Visceral (M1b) or lymph node (M1a) metastasis, up to 5 bone metastasis
Treatment decision for darolutamide by clinician Group 2
High volume bone metastasis (\>5), other sites are allowed (M1a or 1b)
Treatment decision for darolutamide by clinician Group 3
Any metastasis, M1a or 1b)
Treatment decision for darolutamide and docetaxel by clinician
Group 4
Metastatic disease progression on PSA, imaging, or both.
Currently on abiraterone, apalutamide, darolutamide or enzalutamide
PSA progression is defined as 3 consecutive raises above nadir and \> 2ng/ml over a period of 3 months, PSA doubling time \<12 months
Imaging can be any of the following: CT scan, NM bone scan, PSMA PET, MRI.
Prior chemotherapy for mHSPC or CRPC is acceptable, but not mandatory
Any treatment decision by clinician according to patient fitness, wishes and previous treatment according to standard of care protocols for CRCP is allowed.
You may not be if
Group 1-3 already commenced abiraterone, apalutamide, darolutamide or enzalutamide
Group 1-3 already commenced docetaxel for mHSPC
Clareo Health | Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
