Prostate Advances in Comparative Evidence

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT01584258
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prostatectomy — PROCEDURE
    Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.
  • Conventionally Fractionated Prostate Radiotherapy — RADIATION
    Conventional fractionation delivered to a dose of: (PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions
  • Prostate SBRT — RADIATION
    Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.

Study Details

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Key Dates

Start date
Aug 7, 2012
Status verified
Jan 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
2,205 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PACE-A: Prostatectomy vs prostate SBRT
    Low and intermediate risk patients, for whom surgery is considered, will be randomised to prostatectomy vs prostate SBRT delivered with 36.25 Gy in 5 fractions.
  • Active Comparator: PACE-B: Conventionally Fractionated RT vs Prostate SBRT
    Low and intermediate risk patients, for whom surgery is not considered or who refuse surgery, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 78 Gy in 39 fractions or 62 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.
  • Active Comparator: PACE-C: Conventionally Fractionated RT vs Prostate SBRT
    Intermediate and high risk patients, indicated for 6 months ADT, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 60 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.

Primary Outcome Measure

PACE-B and PACE-C: Freedom from biochemical or clinical failure [ Time Frame: 5 years from randomisation (primary timepoint) ]

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