SPCG-17 - when to treat men who are in active surveillance for prostate cancer, a randomized study comparing current practice with standardized triggers for initiation of curative treatment

• Register: ISRCTN
• Last refreshed on: 29 January 2024
• Main ID: ISRCTN64382660
• Date of registration: 20/09/2016
• Prospective Registration: Yes
• Primary sponsor: Uppsala University
• Public title: SPCG-17 - when to treat men who are in active surveillance for prostate cancer, a randomized study comparing current practice with standardized triggers for initiation of curative treatment
• Scientific title: SPCG-17 - Prostate Cancer Active Surveillance Trigger Trial (PCASTT)
• Date of first enrolment: 01/10/2016
• Target sample size: 2000
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN64382660
• Study type: Interventional
• Study design: Randomized multi-centre open-label clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Denmark, England, Finland, Norway, Sweden, United Kingdom

Contacts

• Name: Ulrika Aberg

• Name: Anna Bill-Axelson

Key inclusion & exclusion criteria

Inclusion criteria:
The inclusion criteria are:
1. Recently (within 12 months) diagnosed adenocarcinoma of the prostate
2. Tumour stage = T2a, NX, M0 (former MX)
3. PSA <15 ng/ml, PSA density = 0,2 ng/ml/cc
4. 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 are taken), <10 mm cancer in one core)
5. Life expectancy >10 years with no upper age limit
6. Candidate for curative treatment if progression occurs
7. Signed written informed consent

Exclusion criteria: Participants not fulfilling the inclusion criteria

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Active surveillance for low-risk and favourable intermediate-risk prostate cancer
Cancer
Low- and favourable intermediate-risk prostate cancer

Intervention(s)

Current interventions as of 11/06/2019:

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 initiating curative treatment (experimental arm).

Patients are stratified by centre and Gleason score.

Follow-up in the reference arm (current practice at the trial centre): PSA every 6 months, clinical examination (with PSA test) annually, and MRI (with targeted biopsies at suspicious lesions) every second year. Repeat biopsies and/or other examinations can be initiated according to the urologist’s judgement.

Follow-up in the experimental arm (criteria for intervention): PSA every 6 months, clinical examination (with PSA test) annually, and MRI (with targeted biopsies at suspicious lesions) every second year. Repeat biopsies and/or curative treatment is initiated if specific criteria are fulfilled (see below).

Criteria for repeat biopsies (experimental arm only):
1. A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc
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, high or very-high suspicion of extra-capsular extension or seminal vesicle invasion, or a new lesion with PI-RADS score 3-5)
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)

Criteria for curative tre

Primary Outcome(s)

Current primary outcome measure as of 15/12/2024:
The primary outcome is disease progression, defined as 1) cumulative incidence of PSA relapse after curative treatment or 2) cumulative incidence of androgen deprivation therapy in untreated men still in active surveillance.

The first analysis for the primary endpoint will be performed 1 year after inclusion of the last patient into the study. Subsequent analyses for primary (and secondary) endpoints will be performed every 3 years.



Previous primary outcome measure:
The primary outcome is progression-free survival, which is defined as cumulative incidence of PSA relapse after curative treatment and cumulative incidence of androgen deprivation therapy in untreated men.

The first analysis for the primary endpoint will be performed 1 year after inclusion of the last patient. Subsequent analyses for primary (and secondary) endpoint will be performed every 3 years. Final outcome at 10 years is cumulative prostate cancer mortality.

Secondary Outcome(s)

Current secondary outcome measure as of 15/12/2024:
1. Cumulative incidence of pT3 at radical prostatectomy specimens
2. Cumulative incidence of metastasis (will be assessed after each follow-up examination)
3. Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)
4. Cumulative incidence of switch to watchful waiting
5. Prostate cancer mortality
6. Quality of life (will be assessed from questionnaires at baseline and every 2 years)
7. Costs

The first analysis for secondary endpoints will be performed 1 year after inclusion of the last patient.




Previous secondary outcome measure as of 15/12/2024:
1. Cumulative incidence of pT3 at radical prostatectomy specimens
2. Cumulative incidence of metastasis (will be assessed after each follow-up examination)
3. Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)
4. Cumulative incidence of switch to watchful waiting
5. Quality of life (will be assessed from questionnaires at baseline and every 2 years)
6. Costs

The first analysis for secondary endpoints will be performed 1 year after inclusion of the last patient.

Secondary ID(s)

NCT02914873

Nil known

Source(s) of Monetary Support

Cancerfonden, Svenska Forskningsrådet Formas, Nordic Cancer Union

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Regional Ethical Vetting Board in Uppsala, Sweden, 15/06/2016, ref: 2016/204

Results

• Results available: Yes
• Date Completed: 31/12/2034