International Randomized Study of Laparoscopic Prostatectomy vs Radiosurgery and Conventionally Fractionated Radiotherapy vs Radiosurgery for Early Stage Organ-Confined Prostate Cancer
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical disease-free survival
Biochemical progression is defined as follows: For conventional radiation and radiosurgery arms: Serum PSA of at least 2 ng/mL greater than the post-radiotherapy nadir (lowest PSA to date)(Phoenix definition); for surgical arm: PSA > 0.2 ng/mL. For either arm, a recommencement of androgen deprivation also counts as biochemical failure.
5 years (primary timepoint)
Nicholas van As, MD
Royal Marsden NHS Foundation Trust, London, United Kingdom
United States: Institutional Review Board