SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)
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| ClinicalTrials.gov Identifier: NCT02914873 |
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Recruitment Status :
Recruiting
First Posted : September 26, 2016
Last Update Posted : November 19, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Procedure: Active surveillance | Not Applicable |
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:
- A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
- 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
- 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:
- 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
- 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 (Clinical Trial) |
| Estimated 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 : | October 2016 |
| Estimated Primary Completion Date : | December 2030 |
| Estimated Study Completion Date : | December 2030 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression. |
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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.
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Procedure: Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression. |
- 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.
- 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
- Cumulative incidence of metastases [ Time Frame: Median 10 years follow-up ]Occurrence of distant metastasis (suspected or confirmed) during 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)
- 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
- Quality of life [ Time Frame: Median 10 years follow-up ]Assessed by questionnaire
- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914873
| Contact: Anna Bill-Axelson, MD, PhD | +46 701679747 | anna.bill.axelson@surgsci.uu.se | |
| Contact: Ulrika Aberg, PhD | +46 701679744 | ulrika.aberg@surgsci.uu.se |
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| Principal Investigator: | Anna Bill-Axelson, PhD | Uppsala University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anna Bill-Axelson, Professor, Uppsala University |
| ClinicalTrials.gov Identifier: | NCT02914873 |
| Other Study ID Numbers: |
SPCG-17 |
| First Posted: | September 26, 2016 Key Record Dates |
| Last Update Posted: | November 19, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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prostate cancer active surveillance standardised treatment triggers MRI randomized |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |