Page 164 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Appendix B. Ongoing Randomized Studies Comparing Observational

Management Strategies With Active Treatment Strategies for the Treatment

of Clinically Localized Disease

Study name N centers Population Intervention Comparator(s) Outcomes Current
[Registration] (planned status
Country enrollment)
[enrollment
period]
PIVOT 31 Clinically localized WW RP OS (primary); prostate Preliminary
[Clinical Trials.gov, (731) prostate cancer, within 6 (expectant cancer-specific mortality, results
NCT00007644] [1994-2002] mo of diagnosis, ≤75 yr management with DFS, PFS, morbidity, QoL, presented at
USA palliative therapy) and CE the 2011 AUA
meeting
START 13 Histologically confirmed AS RP or RT, based Prostate cancer-specific Terminated
[Clinical Trials.gov, (2130) adenocarcinoma of the (PSA testing, on patient and mortality (primary); OS, QoL, early (not
NCT00499174] [2007-2011] prostate, within 6 mo of repeat biopsy and physician distant DFS, PSA meeting
Canada, USA, UK diagnosis, clinical stage DRE; radical preference relapse/progression after accrual
T1b-T2b, Gleason score intervention at radical intervention, initiation target)
≤ 6, PSA ≤10 ng/mL, biochemical, of ADT, proportion of patients
physical examination, histological, or on the AS arm who receive
DRE and transrectal US clinical progression) radical intervention ,
within 6 mo of prognostic significance of
randomization, PSA doubling-time prior to
radiographic studies, (if diagnosis,
indicated) negative for prognostic significance of
metastasis, LE >10 yr molecular biomarkers
ProtecT 10 clinically localized AS RP and 3d-CRT OS (primary); disease Followup
[Clinical Trials.gov, (2050) disease prostate cancer (repeat PSA testing (with or without progression, treatment phase
NCT00632983] [2001-ongoing] (T1-T2, NX, M0), 50-69 q3 mo in the first ADT) complications, general health
UK yr, PSA 3.0-19.99 ng/mL, year and then q 6 (2 comparator status, anxiety, depression,
no skeletal metastases mo thereafter; arms) and psychological state,
by isotope bone scan, LE annual review urinary symptoms, QoL,
≥10 yr appointment with sexual function, qualitative
DRE, if indicated) evaluation of outcome by in-
depth interviews
3d-CRT = 3-dimentional conformal radiotherapy; ADT = androgen deprivation therapy; AS = active surveillance; AUA = American Urological Association; CE = cost-
effectiveness; DFS = disease-free survival; DRE = digital rectal examination; LE = life expectancy; mo = month; PIVOT = Prostate Cancer Intervention Versus Observation Trial;
NR = not reported; OS = overall survival; PFS, progression-free survival; ProtecT = Prostate Testing for Cancer and Treatment; PSA = prostate specific antigen; QoL = quality of
life; RP = radical prostatectomy; RT = radiation therapy; START = Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favorable Risk Prostate
Cancer trial; US = ultrasound; yr = year.

B-1