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Prostate Advances in Comparative Evidence (PACE)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

Laproscopic Prostatectomy

Conventionally Fractionated Prostate Radiotherapy

Prostate SBRT

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Prostate adenocarcinoma, Early stage prostate cancer, Organ-confined prostate cancer, Low-risk prostate cancer, Intermediate-risk prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Mount Vernon Cancer CentreRecruiting
Royal Marsden NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Laparoscopic Prostatectomy vs prostate SBRT

Conventionally Fractionated RT vs Prostate SBRT

Arm Description

Patients for whom surgery is considered will be randomised to laparoscopic prostatectomy or prostate SBRT delivered with 36.25 Gy in 5 fractions.

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.

Outcomes

Primary Outcome Measures

Biochemical progression-free survival

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

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

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

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

Progression-free survival

Radiographic, clinical or biochemical evidence of local or distant failure

Commencement of androgen deprivation therapy

LHRH analogues, anti-androgens, orchidectomy

Full Information

NCT ID

NCT01584258

First Posted

April 22, 2012

Last Updated

April 24, 2015

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

The Institute of Cancer Research, Sutton, Surrey, UK

1. Study Identification

Unique Protocol Identification Number

NCT01584258

Brief Title

Prostate Advances in Comparative Evidence

Acronym

PACE

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Recruiting

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

The Institute of Cancer Research, Sutton, Surrey, UK

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate cancer, Prostate adenocarcinoma, Early stage prostate cancer, Organ-confined prostate cancer, Low-risk prostate cancer, Intermediate-risk prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1716 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Prostatectomy vs prostate SBRT

Arm Type

Active Comparator

Arm Description

Patients for whom surgery is considered will be randomised to laparoscopic prostatectomy or prostate SBRT delivered with 36.25 Gy in 5 fractions.

Arm Title

Conventionally Fractionated RT vs Prostate SBRT

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Laproscopic Prostatectomy

Intervention Type

Radiation

Intervention Name(s)

Conventionally Fractionated Prostate Radiotherapy

Intervention Description

Conventional fractionation delivered to a dose of 78 Gy in 2 Gy fractions.

Intervention Type

Radiation

Intervention Name(s)

Prostate SBRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Biochemical progression-free survival

Description

Biochemical progression is defined as follows: For conventional radiation and SBRT arms- Phoenix definition; For surgical arm- PSA > 0.2 ng/mL.

Time Frame

5 years (primary timepoint)

Secondary Outcome Measure Information:

Title

Toxicity assessment for surgical and SBRT arm

Description

CTCAEv4.03 and RTOG for acute and late toxicity. Clavien scale used to assess acute post surgical complications for surgical patients only.

Time Frame

10 years

Title

Toxicity assessment for conventionally fractionated and SBRT arm

Description

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.

Time Frame

10 years

Title

Patient reported outcomes and quality of life assessment for all treatment arms

Description

Time Frame

10 years

Title

Disease-specific and overall survival

Description

Disease-specific and overall survival

Time Frame

10 years

Title

Progression-free survival

Description

Radiographic, clinical or biochemical evidence of local or distant failure

Time Frame

10 years

Title

Commencement of androgen deprivation therapy

Description

LHRH analogues, anti-androgens, orchidectomy

Time Frame

10 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hassan Nawrozzadeh

Phone

+44 208 722 4467

Pace-icrctsu@icr.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Clare Cruickshank

Phone

+44 208 722 4467

Pace-icrctsu@icr.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas van As, MD

Organizational Affiliation

Royal Marsden NHS Foundation Trust, London, United Kingdom

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Peter Ostler, MD

Organizational Affiliation

Mount Vernon Cancer Centre, United Kingdom

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Vernon Cancer Centre

City

London

State/Province

Surrey

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sara Abbassi

Phone

01923-826111

Sara.Abbassi@nhs.net

First Name & Middle Initial & Last Name & Degree

Peter Ostler, MD

Facility Name

Royal Marsden NHS Foundation Trust

City

London

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Henderson, MD

Phone

0207 811 8469

Daniel.Henderson@rmh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Nicholas van As, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

36113498

Citation

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. Erratum In: Lancet Oncol. 2023 May;24(5):e192.

Results Reference

derived

PubMed Identifier

31540791

Citation

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.

Results Reference

derived

Links:

URL

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-surgery-conventional-radiotherapy-and-stereotactic-radiotherapy-for-localised-prostate-cancer-pace

Description

Cancer Research UK- PACE

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Prostate Advances in Comparative Evidence

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