Prostate Advances in Comparative Evidence (PACE)
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ClinicalTrials.gov Identifier: NCT01584258 |
Recruitment Status :
Active, not recruiting
First Posted : April 24, 2012
Last Update Posted : January 19, 2024
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Procedure: Prostatectomy Radiation: Conventionally Fractionated Prostate Radiotherapy Radiation: Prostate SBRT | Phase 3 |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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. |
- 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
- 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.
- All arms: Clinician reported acute toxicity [ Time Frame: 10 years ]CTCAE and RTOG (SBRT and conventional RT patients) or Clavien scale (surgical patients).
- All arms: Clinician reported late toxicity [ Time Frame: 10 years ]CTCAE and RTOG (SBRT and conventional RT patients only).
- 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.
- All arms: Disease-specific and overall survival [ Time Frame: 10 years ]Disease-specific and overall survival
- All arms: Progression-free survival [ Time Frame: 10 years ]Radiographic, clinical or biochemical evidence of local or distant failure
- 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
- 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
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
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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)
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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:
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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
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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).
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
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Prostate cancer Prostate adenocarcinoma Organ-confined prostate cancer Low-risk prostate cancer Intermediate-risk prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |