Prostate Advances in Comparative Evidence (PACE)

Tracking Information
First Submitted Date ICMJE	April 22, 2012
First Posted Date ICMJE	April 24, 2012
Last Update Posted Date	April 27, 2015
Study Start Date ICMJE	April 2012
Estimated Primary Completion Date	September 2021 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 7, 2015)	Biochemical progression-free survival [ Time Frame: 5 years (primary timepoint) ]; Biochemical progression is defined as follows: For conventional radiation and SBRT arms- Phoenix definition; For surgical arm- PSA > 0.2 ng/mL.
Original Primary Outcome Measures ICMJE; (submitted: April 22, 2012)	Biochemical disease-free survival [ Time Frame: 5 years (primary timepoint) ]; 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.
Change History	Complete list of historical versions of study NCT01584258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 7, 2015)	Toxicity assessment for surgical and SBRT arm [ Time Frame: 10 years ]CTCAEv4.03 and RTOG for acute and late toxicity. Clavien scale used to assess acute post surgical complications for surgical patients only.; Toxicity assessment for conventionally fractionated and SBRT arm [ Time Frame: 10 years ]CTCAEv4.03 and RTOG acute and late toxicity scoring. During the treatment period of conventional radiation therapy and SBRT, treatment associated toxicities are assessed using RTOG scoring only.; Patient reported outcomes and quality of life assessment for all treatment arms [ Time Frame: 10 years ]International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), Vaizey score (UK and US patients only) Expanded Prostate Index Composite-26 (EPIC-26) and PR-25 (PR-25 is optional); Disease-specific and overall survival [ Time Frame: 10 years ]Disease-specific and overall survival; Progression-free survival [ Time Frame: 10 years ]Radiographic, clinical or biochemical evidence of local or distant failure; Commencement of androgen deprivation therapy [ Time Frame: 10 years ]LHRH analogues, anti-androgens, orchidectomy
Original Secondary Outcome Measures ICMJE; (submitted: April 22, 2012)	Cause-specific and overall survival [ Time Frame: 10 years ]Cause-specific survival will include deaths from prostate cancer only. Overall survival will include deaths from any cause.; Progression-free survival [ Time Frame: 10 years ]Radiographic or clinical evidence of local, regional or distant failure.; Toxicities associated with surgery, radiotherapy and radiosurgery [ Time Frame: 10 years ]Assessed by CTCAE version 4; Quality of Life [ Time Frame: 10 years ]Using EORTC Quality of Life Questionnaire PR-25
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Prostate Advances in Comparative Evidence
Official Title ICMJE	International Randomised Study of Laparoscopic Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Early Stage Organ-Confined Prostate Cancer
Brief Summary	This study is an international multicentre randomised study of organ confined low and intermediate risk prostate cancer and is composed of two parallel randomisation schemes based on applicability of surgery as a treatment for the patient. Patients for whom surgery is a consideration are randomised to either laparoscopic prostatectomy or prostate SBRT. Patients for whom surgery is not a consideration are randomised to either conventionally fractionated radiation therapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Procedure: Laproscopic Prostatectomy; Radiation: Conventionally Fractionated Prostate Radiotherapy Conventional fractionation delivered to a dose of 78 Gy in 2 Gy fractions.; Radiation: Prostate SBRT Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Study Arms	Active Comparator: Laparoscopic Prostatectomy vs prostate SBRT Patients for whom surgery is considered will be randomised to laparoscopic prostatectomy or prostate SBRT delivered with 36.25 Gy in 5 fractions. Interventions: Procedure: Laproscopic Prostatectomy Radiation: Prostate SBRT; Active Comparator: Conventionally Fractionated RT vs Prostate SBRT 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 2 Gy fractions or SBRT delivered with 36.25 Gy in 5 fractions. Interventions: Radiation: Conventionally Fractionated Prostate Radiotherapy Radiation: Prostate SBRT
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: February 20, 2015)	1716
Original Estimated Enrollment ICMJE; (submitted: April 22, 2012)	1036
Estimated Study Completion Date	September 2026
Estimated Primary Completion Date	September 2021 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: All of the following criteria are mandatory for inclusion: Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken within 18 months of randomisation.; Gleason score ≤ 3+4; Men aged ≥18; Clinical and MRI stage T1c -T2c, N0-X, M0-X (TNM 6th Edition [72], See Appendix 1); PSA ≤ 20 ng/ml; Pre-enrollment PSA must be completed within 60 days of randomisation; Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network (www.nccn.org): Low risk: Clinical stage T1-T2a and Gleason ≤ 6 and PSA < 10 ng/ml, or Intermediate risk includes any one of the following: Clinical stage T2b orT2c PSA 10-20 ng/ml or Gleason 3+4; WHO performance status 0 - 2; Prostate volume ≤ 90 cc measured within 6 months of randomisation (height*width*length *π/6); Ability of the research subject to understand and the willingness to sign a written informed consent document Exclusion criteria: One of the following criteria is sufficient for exclusion: Clinical stage T3 or greater; Gleason score ≥ 4 + 3; High risk disease defined by National Comprehensive Cancer Network (www.nccn.org); Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival; Prior pelvic radiotherapy; Prior androgen deprivation therapy (including LHRH agonists and antagonists and anti-androgens); Any prior active treatment for prostate cancer. Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.; Life expectancy <5 years; Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts; Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms; Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician (see section 11, Treatment).; Participation in another concurrent treatment protocol for prostate cancer
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Hassan Nawrozzadeh +44 208 722 4467 Pace-icrctsu@icr.ac.uk Contact: Clare Cruickshank +44 208 722 4467 Pace-icrctsu@icr.ac.uk
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01584258
Other Study ID Numbers ICMJE	ACCP003
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Royal Marsden NHS Foundation Trust
Study Sponsor ICMJE	Royal Marsden NHS Foundation Trust
Collaborators ICMJE	The Institute of Cancer Research, Sutton, Surrey, UK
Investigators ICMJE	Study Director: Nicholas van As, MD Royal Marsden NHS Foundation Trust, London, United Kingdom Principal Investigator: Peter Ostler, MD Mount Vernon Cancer Centre, United Kingdom
PRS Account	Royal Marsden NHS Foundation Trust
Verification Date	April 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP