Prostate CancerNCT04029714
Prostate Cancer Active Surveillance Trigger Trial (PCASTT-UK): Comparing Current Practice for Men With Prostate Cancer on Active Surveillance (AS) to an AS Protocol With Standardised Triggers for Transitioning to Curative Treatment
A study testing Active Surveillance in people with Prostate Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 5 sites in United Kingdom.
Trial summary
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumour progression occur. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active Surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 19 Sep 2019to Dec 2033
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recently (within 12 months) diagnosed adenocarcinoma of the prostate
- Tumour stage ≤ T2a, NX, M0 (former MX)
- PSA <15ng/ml, PSA density ≤ 0.2 ng/ml/cm3
- Gleason pattern 3+3=6 (any number of cores, any cancer involvement) or Gleason pattern 3+4=7 (<3 cores (or ≤30 % of cores if more than ten cores), <10 mm cancer in one core)
- Life expectancy >10 years with no upper age limit*
- Candidate for curative treatment if progression occurs
- Signed written informed consent.
- There is no upper age limit; however the estimated remaining lifetime for the patient should be more than ten years. The potential life expectancy of the participants should be estimated based on age, co-morbidity and risk factors for death, such as frailty and smoking.
Who cannot join
- Not eligible for AS according to above criteria
- Not competent in spoken or written English
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Bedford Hospital
Bedford
Epsom & St. Helier
London
Guy's Hospital
London
Queen Elizabeth Hospital
London
Royal Mardsen Hospital
London
About this study
Official title: A Multicentre Randomised Active Surveillance (AS) Trial of Current Practice Versus Standardised Triggers for Curative Treatment of Prostate Cancer
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumour progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment.
Therefore, the Scandinavian Prostate Cancer Group (SPCG) are running a large multi-centre randomised control trial (RCT) to test the safety of a standardized active surveillance protocol with specific triggers for repeat biopsies and initiation of curative treatment, compared to the current practice for active surveillance. They are recruiting in multiple sites in Sweden, Denmark and Finland. The primary aim is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.
In the UK, there is also no set criteria for when to re-biopsy and/or initiate curative treatment for patients on AS and tends to be at the clinician's discretion. Thus, PCASTT-UK has been established to run as a parallel RCT and add to the findings from SPCG-17.
Read the detailed description
STUDY HYPOTHESIS The aim of this trial is to test the safety of an Active Surveillance protocol comparing current practice to standardized triggers for initiation of curative treatment, based on Magnetic Resonance Imaging or biopsy pathology. The study hypothesis is that standardized triggers will reduce overtreatment without increasing disease progression and prostate cancer mortality.
STUDY DESIGN Randomized multi-centre open-label clinical trial.
INTERVENTIONS Patients within 12 months of a diagnosis of prostate cancer will be approached and consented to the study. Computerised randomisation (1:1) will assign participants to either the control (Arm 1) or intervention arm (Arm 2). In the control arm, patients will be treated according to active surveillance protocol at the trial centre; in the intervention arm patients will follow standardised active surveillance protocol applying specific criteria for repeat biopsies and the initiation of curative treatment. Patients are stratified by centre and Gleason score.
FOLLOW UP In both arms, patients will followed up for 10 years with the following schedule: a PSA test every 6 months, clinical examination (with PSA test) and Quality of Life (QoL) questionnaire annually, and MRI every second year. Re-biopsy and/or initiation of curative treatment depends on the trial arm patients are randomised to.
Repeat biopsies
Arm 1 (control arm): according to current practice (urologists' judgement)
Arm 2 (intervention arm): standardised triggers
- A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
- MRI progression in men with previously only Gleason grade 3+3: 5 mm or more increase in size in any dimension of a measurable lesion, increase in PI-RADS score to 3-5, a new lesion with PI-RADS score 3-5, or high or very high suspicion of extra-capsular extension or seminal vesicle invasion
- MRI progression in men with Gleason grade 3+4: 5 mm or more increase in size in any dimension of a measurable lesion, or a new lesion with PI-RADS score 3-5
Curative treatment
Arm 1 (control arm): According to current practice (urologists judgement)
Arm 2 (intervention arm): standardised triggers
- MRI progression in lesions with confirmed Gleason grade 4: increase in PI-RADS score to 4 or 5, or high or very high suspicion of extra-capsular extension or seminal vesicle invasion
- Pathological progression: Gleason pattern 5, primary Gleason pattern 4 in any core with 5 mm or more cancer, Gleason 3+4 in 3 or more cores or 30% if more than 10 cores are taken, or Gleason 3+4 in 10 mm or more cancer
Patients will remain on trial unless they end Active Surveillance due to initiation of treatment, development of metastases, transition to watchful waiting, or death of any cause. After the initiation of curative treatment, watchful waiting, or palliative treatment for cancer progression, the patient is treated according to the standard protocol of the participating centre.
- Conditions
- Prostate Cancer
- Being tested
- Active Surveillance
- Keywords
- Prostate Cancer, Active Surveillance, MRI, standardised treatment triggers, randomized
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceProcedure or surgery
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Current practice for active surveillance | Active comparator | In this arm, patients are monitored according to current practice for active surveillance at the trial centre. Repeat biopsies (and/or other examinations) and initiation of curative treatment are performed according to the urologist's judgement. Receives: Procedure: Active Surveillance |
| Arm 2: Standardized triggers for treatment | Experimental | In this arm, patients are monitored according to a standardized active surveillance protocol with specific triggers for treatment. Repeat biopsies and curative treatment are only initiated if/when specific criteria are fulfilled. Receives: Procedure: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is defined as cumulative incidence of PSA relapse following curative treatment and cumulative incidence of androgen therapy in untreated men. Following radical prostatectomy, biochemical recurrence is defined by two consecutively rising PSA values >0.2 ng/ml. After radiotherapy (RT) with or without androgen deprivation therapy, the definition of PSA failure is any rise by 2 ng/ml or more above the nadir PSA value, regardless of the serum concentration of the nadir.
Measured: Median 10 years follow-up
Secondary outcomes (5)
Cumulative incidence of pT3 at radical prostatectomy specimens
Occurrence of confirmed pT3 in radical prostatectomy specimens according to the pathology report
Measured: Median 10 years follow-up
Cumulative incidence of metastases
Occurrence of distant metastasis (suspected or confirmed) during follow-up
Measured: Median 10 years follow-up
Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)
Occurrence of radical prostatectomies or local radiotherapy (with or without adjuvant androgen deprivation therapy)
Measured: Median 10 years follow-up
Cumulative incidence of switch to watchful waiting
Occurrence of conversions from active surveillance to watchful waiting during follow-up
Measured: Median 10 years follow-up
Quality of life assessed by EPIC-26 score, incontinence, erectile dysfunction, self-reported quality of life: questionnaires
Assessed by questionnaires at baseline and every second year.
Quality-of-life data will be presented as proportions with symptoms and relative risks. Outcome variables will be dichotomized using predetermined cut-off values.
The following parameters will be included in the analysis:
- EPIC-26 score
- Incontinence
- Erectile dysfunction
- Self-reported quality of life (rated on a scale of 1-7)
Measured: Median 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start19 Sep 2019
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Uppsala University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029714
- Sponsor's protocol ID
- 228445
- Status last verified
- Feb 2024
- First submitted
- 16 Jul 2019
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Active Surveillance (AS) Trial of Current Practice Versus Standardised Triggers for Curative Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04029714
- Acronym / sponsor ID
- 228445
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, MRI, standardised treatment triggers, randomized
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, Uppsala University
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumour progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment.
Therefore, the Scandinavian Prostate Cancer Group (SPCG) are running a large multi-centre randomised control trial (RCT) to test the safety of a standardized active surveillance protocol with specific triggers for repeat biopsies and initiation of curative treatment, compared to the current practice for active surveillance. They are recruiting in multiple sites in Sweden, Denmark and Finland. The primary aim is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.
In the UK, there is also no set criteria for when to re-biopsy and/or initiate curative treatment for patients on AS and tends to be at the clinician's discretion. Thus, PCASTT-UK has been established to run as a parallel RCT and add to the findings from SPCG-17.
Detailed description
STUDY HYPOTHESIS The aim of this trial is to test the safety of an Active Surveillance protocol comparing current practice to standardized triggers for initiation of curative treatment, based on Magnetic Resonance Imaging or biopsy pathology. The study hypothesis is that standardized triggers will reduce overtreatment without increasing disease progression and prostate cancer mortality.
STUDY DESIGN Randomized multi-centre open-label clinical trial.
INTERVENTIONS Patients within 12 months of a diagnosis of prostate cancer will be approached and consented to the study. Computerised randomisation (1:1) will assign participants to either the control (Arm 1) or intervention arm (Arm 2). In the control arm, patients will be treated according to active surveillance protocol at the trial centre; in the intervention arm patients will follow standardised active surveillance protocol applying specific criteria for repeat biopsies and the initiation of curative treatment. Patients are stratified by centre and Gleason score.
FOLLOW UP In both arms, patients will followed up for 10 years with the following schedule: a PSA test every 6 months, clinical examination (with PSA test) and Quality of Life (QoL) questionnaire annually, and MRI every second year. Re-biopsy and/or initiation of curative treatment depends on the trial arm patients are randomised to.
Repeat biopsies
Arm 1 (control arm): according to current practice (urologists' judgement)
Arm 2 (intervention arm): standardised triggers
- A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
- MRI progression in men with previously only Gleason grade 3+3: 5 mm or more increase in size in any dimension of a measurable lesion, increase in PI-RADS score to 3-5, a new lesion with PI-RADS score 3-5, or high or very high suspicion of extra-capsular extension or seminal vesicle invasion
- MRI progression in men with Gleason grade 3+4: 5 mm or more increase in size in any dimension of a measurable lesion, or a new lesion with PI-RADS score 3-5
Curative treatment
Arm 1 (control arm): According to current practice (urologists judgement)
Arm 2 (intervention arm): standardised triggers
- MRI progression in lesions with confirmed Gleason grade 4: increase in PI-RADS score to 4 or 5, or high or very high suspicion of extra-capsular extension or seminal vesicle invasion
- Pathological progression: Gleason pattern 5, primary Gleason pattern 4 in any core with 5 mm or more cancer, Gleason 3+4 in 3 or more cores or 30% if more than 10 cores are taken, or Gleason 3+4 in 10 mm or more cancer
Patients will remain on trial unless they end Active Surveillance due to initiation of treatment, development of metastases, transition to watchful waiting, or death of any cause. After the initiation of curative treatment, watchful waiting, or palliative treatment for cancer progression, the patient is treated according to the standard protocol of the participating centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Current practice for active surveillance | Active comparator | Procedure: Active SurveillanceIn this arm, patients are monitored according to current practice for active surveillance at the trial centre. Repeat biopsies (and/or other examinations) and initiation of curative treatment are performed according to the urologist's judgement. |
| Arm 2: Standardized triggers for treatment | Experimental | Procedure: Active SurveillanceIn this arm, patients are monitored according to a standardized active surveillance protocol with specific triggers for treatment. Repeat biopsies and curative treatment are only initiated if/when specific criteria are fulfilled. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Recently (within 12 months) diagnosed adenocarcinoma of the prostate
- Tumour stage ≤ T2a, NX, M0 (former MX)
- PSA <15ng/ml, PSA density ≤ 0.2 ng/ml/cm3
- Gleason pattern 3+3=6 (any number of cores, any cancer involvement) or Gleason pattern 3+4=7 (<3 cores (or ≤30 % of cores if more than ten cores), <10 mm cancer in one core)
- Life expectancy >10 years with no upper age limit*
Key exclusion criteria (2 listed)
- Not eligible for AS according to above criteria
- Not competent in spoken or written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active SurveillanceActive monitoring of prostate cancer and curative treatment if there are signs of tumor progression. | Procedure or surgery | Arm 1: Current practice for active surveillance, Arm 2: Standardized triggers for treatment |
Primary outcome
Progression-free survival
Time frame: Median 10 years follow-up
Progression-free survival is defined as cumulative incidence of PSA relapse following curative treatment and cumulative incidence of androgen therapy in untreated men. Following radical prostatectomy, biochemical recurrence is defined by two consecutively rising PSA values >0.2 ng/ml. After radiotherapy (RT) with or without androgen deprivation therapy, the definition of PSA failure is any rise by 2 ng/ml or more above the nadir PSA value, regardless of the serum concentration of the nadir.
5 secondary outcomes
Cumulative incidence of pT3 at radical prostatectomy specimens
Time frame: Median 10 years follow-up
Cumulative incidence of metastases
Time frame: Median 10 years follow-up
Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)
Time frame: Median 10 years follow-up
Cumulative incidence of switch to watchful waiting
Time frame: Median 10 years follow-up
Quality of life assessed by EPIC-26 score, incontinence, erectile dysfunction, self-reported quality of life: questionnaires
Time frame: Median 10 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Surveillance in people with Prostate Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 5 sites in United Kingdom.
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 8 inclusion and 2 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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.
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?
Progression-free survival (time frame: Median 10 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2024.