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Prostate CancerPhase 3PACENCT01584258

Prostate Advances in Comparative Evidence

A Phase 3 study testing Prostatectomy, Conventionally Fractionated Prostate Radiotherapy and Prostate SBRT in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 68 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prostatectomy, Conventionally Fractionated Prostate Radiotherapy and Prostate SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,205 participants
Where
68 sitesin 4 countries
Study dates
7 Aug 2012to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 33Show fewer
  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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).

Trial locations and contacts

68 sites in 4 countries.

68 sites in 4 countries

United Kingdom54 sites

  • Royal United Hospital

    Bath

  • Belfast City Hospital

    Belfast

  • Queen Elizabeth Hospital

    Birmingham

  • Pilgrim Hospital

    Boston

  • Royal Sussex County Hospital

    Brighton

  • Bristol Haematology and Oncology Centre

    Bristol

  • West Suffolk Hospital

    Bury

  • Addenbrooke's Hospital

    Cambridge

  • Queen Elizabeth Hospital

    Cambridge

  • Kent and Canterbury Hospital

    Canterbury

  • Velindre Cancer Centre

    Cardiff, Wales, CF14 2TL

  • Velindre Hospital

    Cardiff

  • Cheltenham General Hospital

    Cheltenham

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • University Hospital Coventry & Warwickshire NHS Trust

    Coventry, West Midlands, CV2 2DX

  • Royal Derby Hospital

    Derby

  • Western General

    Edinburgh

  • Royal Devon and Exeter Hospital

    Exeter

  • The Beatson

    Glasgow

  • Royal Surrey County Hospital

    Guildford

  • Hinchingbrooke Hospital

    Huntingdon, Cambridgeshire, PE29 6NT

  • Ipswich Hospital

    Ipswich

  • Leicester Royal Infirmary

    Leicester

  • Lincoln County Hospital

    Lincoln

  • Mount Vernon Cancer Centre

    London, Surrey, HA6 2RN

  • Royal Free Hospital

    London, NW3 2QC

  • Imperial College, London

    London, W12 0NN

  • Charing Cross Hospital

    London

  • Guy's Hospital

    London

  • North Middlesex University Hospital

    London

  • Royal Marsden NHS Foundation Trust

    London

  • St Bartholomew's Hospital

    London

  • University College Hospital

    London

  • Maidstone Hospital

    Maidstone

  • Christie Hospital

    Manchester

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral

  • James Cook University Hospital

    Middlesbrough

  • Freeman Hospital

    Newcastle upon Tyne

  • Northampton General Hospital

    Northampton

  • Norfolk & Norwich Hospital

    Norwich

  • Nottingham City Hospital

    Nottingham

  • Churchill Hospital

    Oxford, Oxfordshire

  • Peterborough City Hospital

    Peterborough

  • Derriford Hospital

    Plymouth

  • Glan Clwyd Hospital

    Rhyl

  • Queens Hospital

    Romford

  • Weston Park Hospital

    Sheffield

  • Royal Stoke University Hospital

    Stoke-on-Trent

  • Sunderland Royal Hospital

    Sunderland

  • Kings Mill Hospital

    Sutton in Ashfield

  • Torbay District General Hospital

    Torquay

  • Royal Cornwall Hospital

    Truro

  • Southend University Hospital

    Westcliff-on-Sea

  • Worcestershire Royal Hospital

    Worcester

Other trials in United Kingdom

Canada9 sites

  • Northeast Cancer Centre

    Greater Sudbury, Ontario

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • London Health Sciences Centre

    London, Ontario

  • Hôpital Charles-LeMoyne

    Montreal, Quebec

  • Hôpital Maisonneuve Rosemont

    Montreal, Quebec

  • Walker Family Cancer Centre

    Niagara, Ontario

  • Lakeridge Health

    Oshawa, Ontario

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario

  • Odette Cancer Centre

    Toronto, Ontario

Other trials in Canada

Ireland4 sites

  • Beacon Hospital

    Dublin

  • Beaumont Hospital

    Dublin

  • St James's Hospital

    Dublin

  • St. Luke's Hospital

    Dublin

Other trials in Ireland

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer

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.

Conditions
Prostate Cancer
Being tested
Prostatectomy, Conventionally Fractionated Prostate Radiotherapy, Prostate SBRT
Keywords
Prostate cancer, Prostate adenocarcinoma, Organ-confined prostate cancer, Low-risk prostate cancer, Intermediate-risk prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProstatectomyProcedure or surgery

    Radical prostatectomy: performed open, laparoscopically or using a robotically assisted laparoscopic approach.

  • Conventionally Fractionated Prostate RadiotherapyRadiation

    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

  • Prostate SBRTRadiation

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

Study groups in NCT01584258
Study groupRoleWhat they receive
PACE-A: Prostatectomy vs prostate SBRTActive comparatorLow 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.
Receives: Procedure: Prostatectomy; Radiation: Prostate SBRT
PACE-B: Conventionally Fractionated RT vs Prostate SBRTActive comparatorLow 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.
Receives: Radiation: Conventionally Fractionated Prostate Radiotherapy; Radiation: Prostate SBRT
PACE-C: Conventionally Fractionated RT vs Prostate SBRTActive comparatorIntermediate 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.
Receives: Radiation: Conventionally Fractionated Prostate Radiotherapy; Radiation: Prostate SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PACE-B and PACE-C: Freedom from biochemical or clinical failure

    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

    Measured: 5 years from randomisation (primary timepoint)

  2. PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother

    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.

    Measured: 2 years from treatment (primary timepoint)

Secondary outcomes (7)

  1. All arms: Clinician reported acute toxicity

    CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).

    Measured: 10 years

  2. All arms: Clinician reported late toxicity

    CTCAE and RTOG (SBRT and conventional RT patients only).

    Measured: 10 years

  3. All arms: Patient reported acute and late bowel, bladder and erectile dysfunction symptoms.

    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.

    Measured: 10 years

  4. All arms: Disease-specific and overall survival

    Disease-specific and overall survival

    Measured: 10 years

  5. All arms: Progression-free survival

    Radiographic, clinical or biochemical evidence of local or distant failure

    Measured: 10 years

  6. PACE-A and PACE-B: Commencement of androgen deprivation therapy; PACE-C: Re-commencement of androgen deprivation therapy

    LHRH analogues, anti-androgens, orchidectomy

    Measured: 10 years

  7. PACE-A: Freedom from biochemical or clinical failure

    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

    Measured: 5 years from randomisation (primary timepoint)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2012 (estimated)
  2. Study start7 Aug 2012
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentre, international phase 3 randomised controlled study comprising three parallel randomisations with a common experimental arm.
Masking
None (open label)
Enrolment
2,205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01584258
Sponsor's protocol ID
CCR3766
Acronym
PACE
Status last verified
Jan 2024
First submitted
22 Apr 2012
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Tree AC, Hinder V, Chan A, Tolan S, Ostler P, van der Voet H, Kancherla K, Loblaw A, Naismith O, Jain S, Martin A, Price D, Brand D, Chu W, Duffton A, Kelly P, O'Neill B, Staffurth J, Sasso G, Pugh J, Manning G, Brown S, Burnett S, Griffin C, Hall E, van As N; PACE Investigators. Intensity-modulated moderately hypofractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-C): early toxicity results from a randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2025 Jul;26(7):936-947. doi: 10.1016/S1470-2045(25)00205-0. Epub 2025 Jun 12.

    PubMed 40517778

  • Smith RP, Mohammed MA, Beriwal S, Benoit RM. Prostate Brachytherapy With Cs-131: Long-term Results Compared With Published Stereotactic Body Radiotherapy Data. Am J Clin Oncol. 2025 Jan 1;48(1):34-37. doi: 10.1097/COC.0000000000001145. Epub 2024 Oct 17.

    PubMed 39716881

  • van As N, Griffin C, Tree A, Patel J, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Camilleri P, Kancherla K, Frew J, Chan A, Naismith O, Armstrong J, Staffurth J, Martin A, Dayes I, Wells P, Price D, Williamson E, Pugh J, Manning G, Brown S, Burnett S, Hall E. Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. N Engl J Med. 2024 Oct 17;391(15):1413-1425. doi: 10.1056/NEJMoa2403365.

    PubMed 39413377

  • Tree AC, Ostler P, van der Voet H, Chu W, Loblaw A, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Armstrong J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Duffton A, Brand DH, Henderson D, Morrison K, Brown S, Pugh J, Burnett S, Mahmud M, Hinder V, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2022 Oct;23(10):1308-1320. doi: 10.1016/S1470-2045(22)00517-4. Epub 2022 Sep 13.

    PubMed 36113498

  • 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.

    PubMed 31540791

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prostatectomy, Conventionally Fractionated Prostate Radiotherapy and Prostate SBRT in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 68 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United Kingdom, Canada, Ireland, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PACE-B and PACE-C: Freedom from biochemical or clinical failure (time frame: 5 years from randomisation (primary timepoint)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01584258, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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Prostate Advances in Comparative Evidence | AzTrials