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

NCT04029714 | Active Not Recruiting DMC

• 1 other identifier: 228445
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Active Surveillance; MRI; standardised treatment triggers; randomized

Outcome Measures

Primary Outcomes (1)

• 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.

  Median 10 years follow-up

Secondary Outcomes (5)

• Cumulative incidence of pT3 at radical prostatectomy specimens

  Median 10 years follow-up

• Cumulative incidence of metastases

  Median 10 years follow-up

• Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)

  Median 10 years follow-up

• Cumulative incidence of switch to watchful waiting

  Median 10 years follow-up

• Quality of life assessed by EPIC-26 score, incontinence, erectile dysfunction, self-reported quality of life: questionnaires

  Median 10 years follow-up

Study Arms (2)

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.

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.

Procedure: Active Surveillance

Interventions

Active Surveillance PROCEDURE

Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.

Arm 1: Current practice for active surveillance; Arm 2: Standardized triggers for treatment

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not eligible for AS according to above criteria
• Not competent in spoken or written English

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Uppsala University: collaborator

Study Sites (5)

Bedford Hospital

Bedford, United Kingdom

Location

Epsom & St. Helier

London, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

Queen Elizabeth Hospital

London, United Kingdom

Location

Royal Mardsen Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 23, 2019
• Study Start: September 19, 2019
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

GB (5)