Prostate cancer is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall. High risk metastatic castrate sensitive prostate cancer (mCSPC), high-risk locally advanced PC and metastatic castration resistant prostate cancer (mCRPC) are difficult to treat, hence often the focus of studies for new medicines. Locally advanced prostate cancer (PC) patients undergo radical prostectomy (RP) which is a surgical procedure for removal of prostate or receive androgen deprivation therapy (ADT) treatments. There is considerable improvement in patients with localized disease treated with proctectomy however in high-risk patients there is high probability of recurrence in 10 years. mCSPC denotes patients with metastatic prostate cancer disease who continue to respond to ADT. With time, tumors that are sensitive to ADT and resistant to medical or surgical treatments eventually progress to the mCRPC stage.
The introduction of oral medications has offered the benefit of fewer visits to clinics to receive infusion therapy, fewer laboratory tests, and fewer physician visits. However, it is important to explore the disease burden in different PC state to support development of newer treatments. Also, little is known about the overall medication-associated pill-burden that prostate cancer patients experience.
The proposed analyses using real-world data will provide context to the ongoing trials on different PC states (localized/locally advanced, mCSPC and mCRPC). This study will also focus on understanding the disease burden and unmet need among these patients. Additionally, the study will understand different treatment patterns and intake and outcomes in each of these states.
A real-world assessment of the disease burden and unmet needs for patients with high-risk metastatic castrate sensitive prostate cancer (mCSPC), high-risk locally advanced PC and metastatic castration resistant prostate cancer (mCRPC), or locally advanced prostate cancer (PC) will provide context to ongoing clinical trials. Our overall objective is to identify different PC states from CPRD data using linked cancer data using the UK CPRD (Clinical Practice Research Datalink) and to explore pill burden among mCRPC patients. Demographic and clinical characteristics at time of diagnosis of each of the states and outcome will be explored. The Cancer Registry data, Hospital Episode Statistics Admitted Patient Care (HES APC) data, and the National Radiotherapy Dataset data, along with the primary care data, will be used to confirm mCRPC and mCSPC diagnoses via records of PSA test results, primary and secondary cancer diagnoses, medical and surgical castration, and radiotherapy for treatment of metastatic disease, and the Systemic Anti-Cancer Therapy (SACT) data will link mCRPC patients with their cancer-specific therapies. For locally advanced, treatment information (on ADT or RP/RT use within 180 days) will be identified using the registry data. ONS death registration data, in addition to the above linked data sources, will be used for time-to-event outcomes and will be descriptively analyzed using Kaplan-Meier curves. For pill burden, dosage, number of pills per day, frequency per day, and number of cycles for all drug prescriptions will be used to calculate patient pill burden overall for the 3-month period and averaged for each month post-mCRPC diagnosis up to 3 months post-diagnosis. Means, standard deviations, medians and interquartile ranges will be reported for continuous variables, while frequency and percentages will be reported for categorical variables.
Primary outcome(s):
For different clinical states in prostate cancer – localized/locally advanced, mCSPC, and mCRPC.
1. Treatment patterns (including drug-therapy, radiotherapy and radical prostatectomy) in localized/locally advanced, mCSPC and mCRPC.
2. Analyze outcomes such as metastasis free survival (MFS), event free survival (EFS), time to progression to relevant advanced clinical states and overall survival, time to next treatment (TTNT), time to treatment discontinuation (TTD), Prostate Specific Antigen (PSA)-Free survival.
PC state - Index/Start date definition
1a. mCSPC (metastatic castrate sensitive prostate cancer)- For patients who are diagnosed with metastasis at index, start of mCSPC date is considered at index PC diagnosis date
1b. For patients who develop metastasis during follow-up, the date of metastasis diagnosis is considered as mCSPC start date
2. Localized/Locally advanced patients- The start date for the locally advanced setting is the date of ADT/RT/RP treatment within 180 days of PC diagnosis. TNM or Gleason will be used to identify LAPC based on availability
3. mCRPC patients (metastatic castrate resistant PC)- Start of CRPC treatments or date of castration resistance or metastasis whichever occurs later
Secondary outcome(s): pill burden related to mCRPC, mCSPC (may be considered later) and related to other conditions and a categorical pill burden measure
Sandhya Nair - Chief Investigator - Janssen Pharmaceutica NV
Sandhya Nair - Corresponding Applicant - Janssen Pharmaceutica NV
Luis Fernandes - Collaborator - Janssen Pharmaceutica NV
Marcy Schaeffer - Collaborator - Janssen Pharmaceutica NV
Rachael Williams - Collaborator - CPRD
Xiwu Lin - Collaborator - Janssen Global Services LLC
HES Admitted Patient Care;HES Outpatient;NCRAS Cancer Registration Data;NCRAS National Radiotherapy Dataset (RTDS) data;NCRAS Systemic Anti-Cancer Treatment (SACT) data;ONS Death Registration Data