This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostate Advances in Comparative Evidence (PACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01584258
Recruitment Status : Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : January 19, 2024
Sponsor:
Collaborator:
The Institute of Cancer Research, Sutton, Surrey, UK
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Prostatectomy Radiation: Conventionally Fractionated Prostate Radiotherapy Radiation: Prostate SBRT Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre, international phase 3 randomised controlled study comprising three parallel randomisations with a common experimental arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer
Actual Study Start Date : August 7, 2012
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: PACE-A: Prostatectomy vs prostate SBRT
Low and intermediate risk patients, for whom surgery is considered, will be randomised to prostatectomy vs prostate SBRT delivered with 36.25 Gy in 5 fractions.
 Procedure: Prostatectomy
Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.

Radiation: Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Active Comparator: PACE-B: Conventionally Fractionated RT vs Prostate SBRT
Low and intermediate risk 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 39 fractions or 62 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.
 Radiation: Conventionally Fractionated Prostate Radiotherapy

Conventional fractionation delivered to a dose of:

(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions


Radiation: Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
Active Comparator: PACE-C: Conventionally Fractionated RT vs Prostate SBRT
Intermediate and high risk patients, indicated for 6 months ADT, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 60 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.
 Radiation: Conventionally Fractionated Prostate Radiotherapy

Conventional fractionation delivered to a dose of:

(PACE-B) 78 Gy in 39 fractions or 62 Gy in 20 fractions; (PACE-C) 60 Gy in 20 fractions


Radiation: Prostate SBRT
Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PACE-B and PACE-C: Freedom from biochemical or clinical failure [ Time Frame: 5 years from randomisation (primary timepoint) ]

    Biochemical progression is defined as: Phoenix definition

    Clinical progression is defined as: commencement (PACE-B) or re-commencement (PACE-C) of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases


  2. PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother [ Time Frame: 2 years from treatment (primary timepoint) ]

    Urinary incontinence assessed by the number of absorbent pads required per day to control leakage measured by The Expanded Prostate Cancer Index (EPIC) questionnaire.

    Bowel bother assessed by summary score from the EPIC questionnaire.



Secondary Outcome Measures :
  1. All arms: Clinician reported acute toxicity [ Time Frame: 10 years ]
    CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).

  2. All arms: Clinician reported late toxicity [ Time Frame: 10 years ]
    CTCAE and RTOG (SBRT and conventional RT patients only).

  3. All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms. [ Time Frame: 10 years ]
    Assessed using International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), Vaizey score, and Expanded Prostate Index Composite-26 (EPIC-26) instruments.

  4. All arms: Disease-specific and overall survival [ Time Frame: 10 years ]
    Disease-specific and overall survival

  5. All arms: Progression-free survival [ Time Frame: 10 years ]
    Radiographic, clinical or biochemical evidence of local or distant failure

  6. PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy [ Time Frame: 10 years ]
    LHRH analogues, anti-androgens, orchidectomy

  7. PACE-A: Freedom from biochemical or clinical failure [ Time Frame: 5 years from randomisation (primary timepoint) ]

    Biochemical progression is defined as: Phoenix definition (SBRT arm) or >0.2ng/ml (surgical arm)

    Clinical progression is defined as: commencement of androgen deprivation therapy, local recurrence, nodal recurrence and distant metastases



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion critieria (all arms):

  • Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance and not clinically indicated)
  • Men aged ≥18 years at randomisation
  • WHO performance status 0 - 2
  • Patients considered candidates for surgery are eligible for PACE-A; patients not considered candidates for surgery and patients who decline surgery or prefer to avoid surgery are eligible for PACE-B and PACE-C.
  • Ability of the research subject to understand and the willingness to sign a written informed consent document.

Specific risk stratification inclusion criteria for PACE-A and PACE-B:

  • Minimum of 10 biopsy cores.
  • Gleason score ≤ 3+4
  • Clinical and/or MRI stage T1c -T2c, N0-X, M0-X
  • PSA ≤ 20 ng/ml (completed within 60 days of randomisation)
  • Patients belonging to one of the following risk groups:

  • Low risk - patients with tumours meeting all of the following criteria:

    • Gleason ≤ 6
    • Clinical stage T1-T2a
    • PSA < 10 ng/ml (within 60 days prior to randomisation)

  • Intermediate risk - patients with tumours meeting any one of the following criteria:

    • Gleason 3+4
    • Clinical stage T2b or T2c
    • PSA 10-20 ng/ml (within 60 days prior to randomisation)

Specific risk stratification inclusion criteria for PACE-C:

  • Patient planned for a minimum of 6 months ADT (maximum of 12 months). Patients receiving extended androgen deprivation therapy (18 months maximum) to permit safe delay of radiotherapy as a result of the COVID19 pandemic (only) are eligible.
  • Gleason score ≤ 4+4
  • MRI stage T1c -T3a, N0-X, M0-X
  • PSA ≤ 30 ng/ml (within 60 days prior to starting ADT)
  • Patients belonging to one of the following risk groups:

  • Intermediate risk - includes the presence of any of the following, assuming no high risk features apply:

    • Gleason 7 (3+4 or 4+3)
    • T2 (N0, M0-X)
    • PSA 10-20 ng/ml

  • High risk - patients with tumours that meet a maximum of 2 of the following criteria:

    • Gleason 4+4 (max ≤ 50% cores)
    • T3a (N0, M0)
    • PSA >20 ng/ml

Exclusion criteria (all arms):

  • 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 androgen agonists and antagonists) for PACE-A and PACE-B participants.
  • Any prior active treatment for prostate cancer (with the exception of ADT for PACE-C participants). 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 artefacts.
  • Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms.
  • For patients having fiducials inserted: Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician.
  • Participation in another concurrent treatment protocol for prostate cancer.

Specific exclusion criteria for PACE-C:

  • >14 weeks of androgen deprivation therapy prior to randomisation
  • Medical conditions likely to make ADT inadvisable (e.g. significant and ongoing cardiac issues).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584258


Locations
Show Show 68 study locations
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
The Institute of Cancer Research, Sutton, Surrey, UK
Investigators
Layout table for investigator information
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
Principal Investigator: Alison Tree, MD Royal Marsden NHS Foundation Trust, London, United Kingdom
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01584258    
Other Study ID Numbers: CCR3766
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: January 19, 2024
Last Verified: January 2024
Keywords provided by Royal Marsden NHS Foundation Trust:
Prostate cancer
Prostate adenocarcinoma
Organ-confined prostate cancer
Low-risk prostate cancer
Intermediate-risk prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases