Clinical Trial Results:
A 2 arm, phase II controlled randomized trial comparing efficacy and safety of abiraterone and abiraterone associated with Ablative Radiation Therapy in patients with Oligometastatic castration resistant prostate cancer (ARTO trial)
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Summary
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EudraCT number |
2016-005284-13 |
Trial protocol |
IT |
Global end of trial date |
10 Sep 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Jan 2025
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First version publication date |
16 Jan 2025
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Other versions |
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Summary report(s) |
Full published article |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ARTO
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Dipartimento "Mario Serio" Univ. studi Firenze
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Sponsor organisation address |
Largo Brambilla 3, Florence, Italy,
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Public contact |
Data Manager, Dipartimento "Mario Serio" Univ. studi Firenze, +39 0557947192, datamanager.ng.rt@sbsc.unifi.it
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Scientific contact |
Data Manager, Dipartimento "Mario Serio" Univ. studi Firenze, +39 0557947192, datamanager.ng.rt@sbsc.unifi.it
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Sep 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Sep 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Sep 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary objective of the study will be PSA response >50% measured within 6 months.in nodal and/or bone oligometastatic (¿ 3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).
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Protection of trial subjects |
The study was performed according to the Declaration of Helsinki principles. Informed consent to participate in the study
was obtained from each enrolled patient.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 157
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Worldwide total number of subjects |
157
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EEA total number of subjects |
157
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
157
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85 years and over |
0
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Recruitment
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Recruitment details |
Enrollment start in 2018 and ended in September 2022 | |||||||||
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Pre-assignment
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Screening details |
None | |||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
None
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Control | |||||||||
Arm description |
Abiraterone alone | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Abiraterone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1000 mg day
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Arm title
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Treatment | |||||||||
Arm description |
Abiraterone+SBRT | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Abiraterone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1000 mg day
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End points reporting groups
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Reporting group title |
Control
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Reporting group description |
Abiraterone alone | ||
Reporting group title |
Treatment
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Reporting group description |
Abiraterone+SBRT | ||
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End point title |
Biochemical response | |||||||||
End point description |
The difference between the two arms in terms of biochemical response (BR) rate (defined as percentage of patients with a
PSA decrease ≥50% compared with baseline) at 6 months after AAP treatment start was the primary end point of the trial
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End point type |
Primary
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End point timeframe |
6 months
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Statistical analysis title |
Statistical analysis | |||||||||
Statistical analysis description |
The distribution of categorical and continuous variables was
compared between the control and the treatment arms by
means of Fisher’s exact and Wilcoxon’s rank sum tests,
respectively. The effect of the arm allocation (experimental v
control) and baseline covariates (baseline PSA for each increase by 1 ng/mL, the number of metastatic sites 1 v >1,
restaging at enrollment with PSMA/fluciclovine PET v every
other method, presence of bone metastasis v nodal only
disease, and de novo metastat
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Comparison groups |
Control v Treatment
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Number of subjects included in analysis |
157
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Regression, Cox | |||||||||
Parameter type |
Hazard ratio (HR) | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
January 2018- September 2024
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
2.1
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Adverse events are reported in the published article |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
