SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)

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ClinicalTrials.gov Identifier: NCT02914873

Recruitment Status : Recruiting

First Posted : September 26, 2016

Last Update Posted : May 9, 2018

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Sponsor:

Information provided by (Responsible Party):

Anna Bill-Axelson, Uppsala University

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 disease	Intervention/treatment	Phase
Prostate Cancer	Procedure: Active surveillance	Not Applicable

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 over-treatment 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 multiparametric 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 new 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 new 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 Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Anna Bill-Axelson, PhD	+46 701679747	anna.bill.axelson@surgsci.uu.se
Contact: Ulrika Aberg, PhD	+46 701679744	ulrika.aberg@surgsci.uu.se

Locations


Sweden
Akademiska hospital	Recruiting
Uppsala, Sweden, 75185
Contact: Anna Bill-Axelson, MD, ass prof anna.bill.axelson@surgsci.uu.se
Contact: Monica G Andersson, RN monika.g.andersson@akademiska.se

Sponsors and Collaborators

Uppsala University

Investigators


Principal Investigator:	Anna Bill-Axelson, PhD	Uppsala University

More Information


Responsible Party:	Anna Bill-Axelson, Associate professor, Uppsala University
ClinicalTrials.gov Identifier:	NCT02914873 History of Changes
Other Study ID Numbers:	SPCG-17
First Posted:	September 26, 2016 Key Record Dates
Last Update Posted:	May 9, 2018
Last Verified:	May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Anna Bill-Axelson, Uppsala University:


prostate cancer active surveillance standardised treatment triggers MRI randomized

Additional relevant MeSH terms:


Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site	Neoplasms Genital Diseases, Male Prostatic Diseases

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