SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)

December 15, 2022 updated by: Anna Bill-Axelson, Uppsala University

SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)

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 tumor progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. The investigators are therefore starting a large randomized multicenter trial testing the safety of a standardized active surveillance protocol with specified triggers for repeat biopsies and initiation of curative treatment. The standardized protocol is compared with current practice for active surveillance. The primary aim of the study is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

STUDY HYPOTHESIS

The study hypothesis is that standardized triggers for initiation of curative treatment of men who are in active surveillance will reduce overtreatment without increasing disease progression and prostate cancer mortality.

STUDY DESIGN

Randomized multi-centre open-label clinical trial

INTERVENTIONS

Computerized randomisation (1:1) within 12 months from diagnosis of prostate cancer, either to active surveillance according to current practice at the trial centre (reference arm), or to a standardised active surveillance protocol applying specific criteria for repeat biopsies and the initiation of curative treatment (experimental arm). Patients are stratified by centre and Gleason score.

Follow-up both groups: PSA every 6 months, clinical examination (with PSA test) annually, and MRI every second year.

Repeat biopsies (reference arm): Current practice

Repeat biopsies (experimental arm), standardised triggers:

  1. A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
  2. 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
  3. 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 (reference arm): Current practice

Curative treatment (experimental arm), standardised triggers:

  1. 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
  2. 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 be followed continuously until initiation of treatment, the event of metastasis, to a break point where active surveillance is considered terminated and watchful waiting starts, or to death of any cause. After the initiation of curative treatment, watchful waiting, or palliative treatment for cancer progression, the patient is followed according to the standard protocol of the participating centre.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Recently (within 12 months) diagnosed adenocarcinoma of the prostate
  • Tumor stage less than or equal to T2a, NX, M0
  • PSA less than 15 ng/ml, PSA density less than or equal to 0.2 ng/ml/cc
  • Gleason pattern 3+3=6 (any number of cores, any cancer involvement)
  • Gleason pattern 3+4=7 (less than 3 cores (or less than 30% of cores if more than 10 cores are taken), less than 10 mm cancer in one core)
  • Life expectancy more than 10 years with no upper age limit
  • Candidate for curative treatment if progression occurs
  • Signed written informed consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Current practice for active surveillance
In this arm, patients are monitored according to current practice for active surveillance at the trial centre. Repeat biopsies (and/or other examinations) and curative treatment are performed according to the urologist's judgement.
Procedure: Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
Experimental: Standardized triggers for treatment
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
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Median 10 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of pT3 at radical prostatectomy specimens
Time Frame: Median 10 years follow-up
Occurrence of confirmed pT3 in radical prostatectomy specimens according to the pathology report
Median 10 years follow-up
Cumulative incidence of metastases
Time Frame: Median 10 years follow-up
Occurrence of distant metastasis (suspected or confirmed) during follow-up
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
Occurrence of radical prostatectomies or local radiotherapy (with or without adjuvant androgen deprivation therapy)
Median 10 years follow-up
Cumulative incidence of switch to watchful waiting
Time Frame: Median 10 years follow-up
Occurrence of conversions from active surveillance to watchful waiting during follow-up
Median 10 years follow-up
Quality of life
Time Frame: Median 10 years follow-up
Assessed by questionnaire
Median 10 years follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative prostate cancer mortality
Time Frame: Final effect measure at 10 years of follow-up
Final endpoint at 10 years of follow-up is prostate cancer mortality, with competing causes of death taken into account
Final effect measure at 10 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Anna Bill-Axelson, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2033

Study Completion (Anticipated)

December 1, 2033

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPCG-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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