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Prostate Advances in Comparative Evidence (PACE)

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ClinicalTrials.gov Identifier: NCT01584258
Recruitment Status : Recruiting
First Posted : April 24, 2012
Last Update Posted : April 27, 2015
Sponsor:
Collaborator:
The Institute of Cancer Research, Sutton, Surrey, UK
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 * Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Henderson D, Brown S, Cruickshank C, Burnett S, Duffton A, Griffin C, Hinder V, Morrison K, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019 Nov;20(11):1531-1543. doi: 10.1016/S1470-2045(19)30569-8. Epub 2019 Sep 17.

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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