PCASTT: SPCG17: Prostate Cancer Active Surveillance Trigger Trial

Sponsor
Uppsala University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02914873
Collaborator
(none)
2,000
Enrollment
20
Locations
2
Arms
170
Duration (Months)
100
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Active surveillance
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [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.

Secondary Outcome Measures

  1. Cumulative incidence of pT3 at radical prostatectomy specimens [Median 10 years follow-up]

    Occurrence of confirmed pT3 in radical prostatectomy specimens according to the pathology report

  2. Cumulative incidence of metastases [Median 10 years follow-up]

    Occurrence of distant metastasis (suspected or confirmed) during follow-up

  3. Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy) [Median 10 years follow-up]

    Occurrence of radical prostatectomies or local radiotherapy (with or without adjuvant androgen deprivation therapy)

  4. Cumulative incidence of switch to watchful waiting [Median 10 years follow-up]

    Occurrence of conversions from active surveillance to watchful waiting during follow-up

  5. Quality of life [Median 10 years follow-up]

    Assessed by questionnaire

Other Outcome Measures

  1. Cumulative prostate cancer mortality [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Odense University HospitalOdenseDenmark
2Helsinki University HospitalHelsinkiFinland
3Seinäjoki Central HospitalTampereFinland
4Oslo University HospitalOsloNorway
5University Hospital of North NorwayTromsøNorway
6St Olavs University HospitalTrondheimNorway
7Hospital of VestfoldTønsbergNorway
8Ålesund Regional HospitalÅlesundNorway
9Sahlgrenska University HospitalGöteborgSweden
10Linköping University HospitalLinköpingSweden
11Sunderby Regional HospitalLuleåSweden
12Sundsvall Regional HospitalSundsvallSweden
13Umeå University HospitalUmeåSweden
14Akademiska University HospitalUppsalaSweden
15Växjö HospitalVäxjöSweden
16Örebro University HospitalÖrebroSweden
17Epsom and St Helier HospitalLondonUnited Kingdom
18Guy's HospitalLondonUnited Kingdom
19King's College HospitalLondonUnited Kingdom
20Royal Marsden HospitalLondonUnited Kingdom

Sponsors and Collaborators

  • Uppsala University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Anna Bill-Axelson, Professor, Uppsala University
ClinicalTrials.gov Identifier:
NCT02914873
Other Study ID Numbers:
  • SPCG-17
First Posted:
Sep 26, 2016
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Anna Bill-Axelson, Professor, Uppsala University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021