Prostate Advances in Comparative Evidence (PACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Royal Marsden NHS Foundation Trust
Sponsor:
Collaborator:
The Institute of Cancer Research, Sutton, Surrey, UK
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01584258
First received: April 22, 2012
Last updated: April 24, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Procedure: Laproscopic Prostatectomy
Radiation: Conventionally Fractionated Prostate Radiotherapy
Radiation: Prostate SBRT
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 Randomised Study of Laparoscopic Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Early Stage Organ-Confined Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Biochemical progression-free survival [ Time Frame: 5 years (primary timepoint) ] [ Designated as safety issue: No ]
    Biochemical progression is defined as follows: For conventional radiation and SBRT arms- Phoenix definition; For surgical arm- PSA > 0.2 ng/mL.


Secondary Outcome Measures:
  • Toxicity assessment for surgical and SBRT arm [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Disease-specific and overall survival

  • Progression-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Radiographic, clinical or biochemical evidence of local or distant failure

  • Commencement of androgen deprivation therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    LHRH analogues, anti-androgens, orchidectomy


Estimated Enrollment: 1716
Study Start Date: April 2012
Estimated Study Completion Date: September 2026
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Laproscopic Prostatectomy Radiation: Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
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.
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.

  Eligibility

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

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
  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

Contacts
Contact: Hassan Nawrozzadeh +44 208 722 4467 Pace-icrctsu@icr.ac.uk
Contact: Clare Cruickshank +44 208 722 4467 Pace-icrctsu@icr.ac.uk

Locations
United Kingdom
Mount Vernon Cancer Centre Recruiting
London, Surrey, United Kingdom, HA6 2RN
Contact: Sara Abbassi    01923-826111    Sara.Abbassi@nhs.net   
Principal Investigator: Peter Ostler, MD         
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Daniel Henderson, MD    0207 811 8469    Daniel.Henderson@rmh.nhs.uk   
Principal Investigator: Nicholas van As, MD         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
The Institute of Cancer Research, Sutton, Surrey, UK
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01584258     History of Changes
Other Study ID Numbers: ACCP003
Study First Received: April 22, 2012
Last Updated: April 24, 2015
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 Royal Marsden NHS Foundation Trust:
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on April 26, 2015