Prostate Advances in Comparative Evidence (PACE)

This study has been terminated.
(Study sponsorship has transitioned to the Royal Marsden (UK).)
Sponsor:
Collaborators:
Royal Marsden NHS Foundation Trust, London, UK
Mount Vernon Cancer Center, East & North Herts NHS Trust,Northwood,Middlesex, UK
Centre Oscar Lambret, Lille, France
Charite University, Berlin, Germany
Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam, The Netherlands
The Institute of Cancer Research, Sutton, Surrey, UK
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT01584258
First received: April 22, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This study is an international multicenter randomized study of organ confined low and intermediate risk prostate cancer and is composed of two parallel randomization schemes based on applicability of surgery as a treatment for the patient. Patients for whom surgery is a consideration are randomized to either laparoscopic or da Vinci prostatectomy or CyberKnife prostate SBRT(also known as CyberKnife radiosurgery). Patients for whom surgery is not a consideration are randomized to either conventionally fractionated radiation therapy or CyberKnife prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomization.


Condition Intervention Phase
Prostate Cancer
Other: CyberKnife prostate SBRT delivered by the CyberKnife in 36.25Gy in 5 fractions or 38Gy in 4 fractions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Randomized Study of Laparoscopic Prostatectomy vs Radiosurgery and Conventionally Fractionated Radiotherapy vs Radiosurgery for Early Stage Organ-Confined Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:
  • Biochemical disease-free survival [ Time Frame: 5 years (primary timepoint) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Cause-specific and overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Radiographic or clinical evidence of local, regional or distant failure.

  • Toxicities associated with surgery, radiotherapy and radiosurgery [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Assessed by CTCAE version 4

  • Quality of Life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Using EORTC Quality of Life Questionnaire PR-25


Enrollment: 136
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic prostatectomy vs CyberKnife prostate SBRT
Patients for whom surgery is considered will be randomized to laparoscopic prostatectomy (manual laparoscopic prostatectomy or da Vinci prostatectomy) or CyberKnife prostate SBRT.
Other: CyberKnife prostate SBRT delivered by the CyberKnife in 36.25Gy in 5 fractions or 38Gy in 4 fractions
CyberKnife prostate SBRT delivered by the CyberKnife in 36.25Gy in 5 fractions or 38Gy in 4 fractions.
Active Comparator: Conventionally fractionated RT vs CyberKnife prostate SBRT
Patients for whom surgery is not considered or who refuse surgery will be randomized to either conventionally fractionated radiotherapy or CyberKnife SBRT.
Other: CyberKnife prostate SBRT delivered by the CyberKnife in 36.25Gy in 5 fractions or 38Gy in 4 fractions
CyberKnife prostate SBRT delivered by the CyberKnife in 36.25Gy in 5 fractions or 38Gy in 4 fractions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken.
  • Gleason score ≤ 3+4
  • Men aged ≥18
  • Clinical and MRI stage T1c -T2c, N0-X, M0-X
  • PSA ≤ 20 ng/mL
  • Pre-enrollment PSA must be completed within 60 days of registration
  • Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network:

    • 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 or T2c
      • PSA 10-20 ng/ml or
      • Gleason 7
  • WHO performance status 0 - 2
  • Prostate volume ≤ 90 cc
  • Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Clinical stage T3 or greater
  • Gleason score ≥ 4 + 3
  • < 10 prostate biopsies taken
  • High risk disease as defined by National Comprehensive Cancer Network (www.nccn.org)
  • Previous malignancy within last 5 years except basal cell carcinoma or squamous cell carcinoma of the skin
  • Prior pelvic radiotherapy
  • Prior androgen deprivation therapy (including androgen agonists and antagonists)
  • Any prior active treatment for prostate cancer
  • Life expectancy <10 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 or bleeding tendency making fiducial placement unsafe.
  • Medical condition/ implant that prohibits MRI
  • Comorbidity that excludes surgery (patients can still be entered into radiotherapy randomization arm)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584258

Locations
United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Accuray Incorporated
Royal Marsden NHS Foundation Trust, London, UK
Mount Vernon Cancer Center, East & North Herts NHS Trust,Northwood,Middlesex, UK
Centre Oscar Lambret, Lille, France
Charite University, Berlin, Germany
Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam, The Netherlands
The Institute of Cancer Research, Sutton, Surrey, UK
Investigators
Principal Investigator: Nicholas van As, MD Royal Marsden NHS Foundation Trust, London, United Kingdom
Study Chair: Shafak Aluwini, MD Erasmus MC, Rotterdam, the Netherlands
Study Chair: Volker Budach, MD Charité - Universitätsmedizin Berlin, Germany
Study Chair: Luca Incrocci, MD Erasmus MC, Rotterdam, the Netherlands
Study Chair: Eric Lartigau, MD Centre Oscar Lambret, Lille, France
Study Chair: Peter Ostler, MD Mount Vernon Cancer Centre, United Kingdom
Study Chair: Alan Thompson, MD Royal Marsden NHS Foundation Trust, London, United Kingdom
  More Information

Additional Information:
No publications provided

Responsible Party: Accuray Incorporated
ClinicalTrials.gov Identifier: NCT01584258     History of Changes
Other Study ID Numbers: ACCP003
Study First Received: April 22, 2012
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research

Keywords provided by Accuray Incorporated:
Prostate cancer
Prostate adenocarcinoma
Early stage prostate cancer
Organ-confined prostate cancer
Low-risk prostate cancer
Intermediate-risk prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014