International randomised study of laparoscopic prostatectomy vs stereotactic body radiotherapy (SBRT) and conventionally fractionated radiotherapy vs SBRT for early stage organ-confined prostate cancer
The aim of this study is to assess whether hypofractionated stereotactic body radiotherapy (SBRT) offers therapeutic benefit over prostatectomy or conventionally fractionated radiotherapy for people with early stage organ-confined prostate cancer. Profound hypofractionation with SBRT has the potential to achieve equivalent tumour control rates compared to surgery and conventional radiotherapy while reducing radiation to normal tissues (bladder, rectal and penile bulb) and minimising radiation-induced side effects.
Chelsea NRES, 25/01/12, ref: 11/LO/1915
Randomised; Interventional; Design type: Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Topic: Cancer, Surgery; Subtopic: Prostate Cancer, Surgery; Disease: Prostate
1. Radiotherapy: Conventionally fractionated radiotherapy: delivered to a dose of 78 Gy in 2 Gy fractions
2. SBRT - hypofractionated stereotactic body radiotherapy: delivered to a dose of 36.25 Gy in 5 fractions
3. Surgery: laparoscopic prostatectomy
Primary outcome measures
Biochemical progression-free survival: Phoenix definition for conventional radiotherapy and SBRT arms, >0.2 ng/ml for surgical arm. The main time point of interest is 5 years post treatment.
Secondary outcome measures
1. Toxicity assessment for surgical and SBRT arm: CTCAE and RTOG for acute and late toxicity. Clavien scale used to assess acute post-surgical complications for surgical patients only.
2. Toxicity assessment for conventionally fractionated and SBRT arm: CTCAE and RTOG acute and late toxicity scoring
3. Patient reported outcomes and quality of life assessment for all treatment arms: Erectile function (IIEF-5), IPSS, Vaizey score, EPIC-26 and PR-25.
4. Disease-specific and overall survival
5. Progression-free survival: radiographic, clinical or biochemical evidence of local or distant failure.
6. Commencement of androgen deprivation therapy ( LHRH analogues, anti-androgens, orchidectomy).
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken within last 18 months.
2. Gleason score = 3+4
3. Men aged at least18
4. Clinical and MRI stage T1c –T2c, N0-X, M0-X
5. PSA = 20 ng/ml
6. Pre-enrollment PSA must be completed within 60 days of registration
7. Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network (www.nccn.org):
7.1. Low risk: Clinical stage T1-T2a and Gleason = 6 and PSA < 10 ng/ml, or
7.2. Intermediate risk includes any one of the following:
7.2.1. Clinical stage T2b orT2c
7.2.2. PSA 10-20 ng/ml
7.2.3. Gleason 7
8. WHO performance status 0 - 2
9. Prostate volume = 90 cc measured within 6 months of randomisation
10. Ability of the research subject to understand and the willingness to sign a written informed consent document
Target number of participants
Planned Sample Size: 1716; UK Sample Size: 200
Participant exclusion criteria
1. Clinical stage T3 or greater
2. Gleason score = 4 + 3
3. High risk disease defined by National Comprehensive Cancer Network (www.nccn.org)
4. < 10 prostate biopsies taken
5. Previous malignancy within last 5 years except basal cell carcinoma or squamous cell carcinoma of the skin
6. Prior pelvic radiotherapy
7. Prior androgen deprivation therapy (including androgen agonists and antagonists)
8. Any prior active treatment for prostate cancer. Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
9. Prior transurethral resection of the prostate (TURP) for benign prostatic hypertrophy
10. Life expectancy <5 years
11. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
12. Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms
13. Anticoagulation with warfarin/bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician.
14. Medical condition/ implant that prohibits MRI
15. Participation in another concurrent treatment protocol
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Royal Marsden NHS Foundation Trust
Trial participating centre
East and North Hertfordshire NHS Trust
Mount Vernon Cancer Centre, The Clock Tower, Rickmansworth Road, Northwood
Accuray Incorporated (USA)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The main trial results will be published in a peer-reviewed journal, on behalf of all collaborators. The manuscript will be prepared by a writing group, consisting of members of the Trial Management Group, and participating clinicians. All participating clinicians will be acknowledged in the publication.
All presentations and publications relating to the trial must be authorised by the Trial Management Group. Authorship of any secondary publications, e.g, will reflect the intellectual and time input into these studies. No Investigator may present or attempt to publish data relating to the PACE trial without prior permission from the Trial Management Group.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting