Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work.
The main aims of the study are:
* to check the safety of PRL-02 depot given with and without another medicine called enzalutamide. * to check if the men can tolerate PRL-02 depot given with or without enzalutamide. * to find a suitable dose of PRL-02 depot.
This study will be in 2 parts.
In the first part, different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines.
In the second part of the study, men who have previously taken a hormone therapy called abiraterone acetate or have previously taken 1 specific hormone therapy as part of their prostate cancer treatment can take part.
Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks. They will also take dexamethasone or prednisone, or enzalutamide once a day. The other medicines they take depend on which group and which part of the study they are in.
During the study, the men will visit the clinic several times for health checks and scans.
After the final visit, men whose cancer has not become worse will continue to have health checks and scans every few months.
Histological evidence of adenocarcinoma of the prostate
mCSPC (must have documentation by positive bone scan [for bone disease] or metastatic lesions on computed tomography [CT] or magnetic resonance imaging [MRI] scan [for soft tissue])
nmCSPC with biochemical relapse of prostate cancer
mCSPC with oligometastatic prostate cancer (e.g., positron emission tomography positive)
Known active central nervous system (CNS) metastases. Note: Participants with CNS metastases that have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable are eligible.
Impending bone fracture due to bone metastases
Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type
Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years
Sequential
PRL-02 injection
Drugabiraterone decanoate for intramuscular injection
prednisone
DrugOral dose
dexamethasone
DrugOral dose
enzalutamide
DrugOral capsule
Incidence of Dose Limiting Toxicities (DLTs)
A DLT is defined as any event meeting the DLT criteria during the first 28 days of each Dose Escalation treatment regardless of attribution to the study drug unless due to underlying disease or extraneous causes.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants with Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other medically important events.
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Pharmacokinetics (PK) of Abiraterone in plasma: Maximum Concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
PK of Abiraterone Decanoate in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
PK of Abiraterone Metabolite in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
PK of Abiraterone in plasma: Minimum Concentration (Cmin)
Cmin will be recorded from the PK plasma samples collected.
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