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

SPCG-17 - Prostate Cancer Active Surveillance Trigger Trial (PCASTT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64382660

Enrollment

2000

Registered

2016-09-20

Start date

2016-10-01

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion 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 10 years with no upper age limit 6. Candidate for curative treatment if progression occurs 7. Signed written informed consent

Exclusion criteria

Exclusion criteria: Participants not fulfilling the inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

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

Contacts

Public ContactUlrika Aberg

ulrika.aberg@uu.se0046701679744

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026