EDC for prostate cancer clinical trials

Prostate cancer is a spectrum from localized disease managed with radiotherapy, surgery or surveillance to metastatic hormone-sensitive and castration-resistant disease. The endpoint changes along that spectrum: biochemical recurrence or metastasis-free survival in earlier settings, and radiographic progression-free survival (rPFS) and overall survival in advanced disease. Registered metastatic protocols commonly define rPFS as the time from randomization to the first documented radiographic progression or death, which means every scan date, and the way each scan was read, becomes endpoint data.

PSA is the signature measurement. Registered protocols that follow the Prostate Cancer Working Group approach describe PSA progression relative to the nadir: for a participant whose PSA fell, a rise of at least 25 percent and at least 2 ng/mL above the nadir, not counted before 12 weeks and confirmed by a second value at least 3 weeks later. Details differ between trials, so treat the numbers as a pattern and use your own protocol. What matters for the EDC is that you capture every value with its date and unit, store the nadir explicitly and record the confirmation sample, so any definition can be applied later.

Imaging is read on two tracks. Soft-tissue disease is usually assessed with RECIST 1.1 in modified form, while bone progression follows its own rules, commonly based on new bone lesions with confirmation on a later scan. Build separate forms or sections so the bone read, the soft-tissue read and the investigator’s overall call each have their own date and result, and so a confirmation scan can be linked to the first scan that triggered it.

Prostate studies often run for years, so safety data is dominated by cumulative and chronic effects. Hormonal therapy commonly brings fatigue, hot flashes, loss of bone density and changes in metabolic and cardiovascular risk, and newer agents bring their own signals that the protocol will name. Each adverse event needs onset, CTCAE grade, seriousness, relationship and action, and events of special interest, such as particular cardiovascular terms, benefit from a dedicated flag so they are easy to pull for review.

Capture vital signs, weight and the relevant laboratory values at the schedule the protocol sets, using the vital signs form and the laboratory form, and add range-based edit checks for values that need attention. For participants taking oral agents, adherence and dose interruptions matter for exposure analysis; the medication adherence page shows how dispensing and counts are structured, and IMP inventory and drug accountability covers supply.

Check a term against published criteria with the CTCAE grade lookup; the investigator assigns the grade. Serious events use the SAE report form and the SAE reporting deadline calculator.