Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004080

Trial Description

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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

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Trial Acronym

PACE

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004080
  •   2012/08/27
  •   2012/04/22
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Secondary IDs

  •   NCT01584258  (ClinicalTrials.gov)
  •   ACCP003  (Accuray Incorporated)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Procedure: Laproscopic Prostatectomy
  •   Radiation: Conventionally Fractionated Prostate Radiotherapy
  •   Radiation: Prostate SBRT
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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.

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Secondary Outcome

- 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

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Countries of Recruitment

  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/04/30
  •   1716
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion 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

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Exclusion Criteria

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Addresses

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    • Royal Marsden NHS Foundation Trust
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    • The Institute of Cancer Research, Sutton, Surrey, UK
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    • Royal Marsden NHS Foundation Trust, London, United Kingdom
    • Nicholas van As, MD 
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    • Hassan Nawrozzadeh 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.