Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000097145
Ethics application status
Approved
Date submitted
2/12/2018
Date registered
23/01/2019
Date last updated
10/05/2019
Date data sharing statement initially provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined radiotherapy and immunotherapy for men with early metastatic prostate cancer not on hormone therapy
Scientific title
A phase II, open label study of durvalumab (medi4736) in combination with stereotactic body radiotherapy (sbrt) in androgen-intact patients with oligo metastatic prostate cancer measuring psa response
Secondary ID [1] 296615 0
ESR-17-12812
Universal Trial Number (UTN)
Trial acronym
CAPRI
Linked study record
NOT APPLICABLE

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 310645 0
Condition category
Condition code
Cancer 309359 309359 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Durvalumab fixed dose 1500mg intravenously every 4 weeks for one year. Durvalumab will be administered in the Day Therapy Unit under direct observation by study personnel
Radiotherapy to metastases given one month after first dose of Durvalumab. Radiotherapy doses will be 30 Gray in 3 fractions to gross lymph nodes two treatmetns per week or 55 Gray in 20 fractions to gross lymph nodes and 45 Gray in 20 fractions (all fractions given daily Monday to Friday) to at risk draining lymph nodesor Stereotactic Body Radiotherapy 24 Gray in two fractions given over one week
Intervention code [1] 313072 0
Treatment: Drugs
Intervention code [2] 313073 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308316 0
PSA progression free survival defined as time to post treatment nadir PSA + 0.2 ug/L. PSA will be assessed by monthly blood tests.
Timepoint [1] 308316 0
12 months post enrollment
Primary outcome [2] 308317 0
Toxicity as assessed by CTCAE version 4 criteria
Timepoint [2] 308317 0
12 months post enrollment
Secondary outcome [1] 354602 0
Biochemical (PSA) response rate as assessed by serum PSA measurements
Timepoint [1] 354602 0
12 months post enrollment

Eligibility
Key inclusion criteria
• adenocarcinoma prostate treated definitively with either radiotherapy or surgery
• disease free interval of > 24mths from definitive management
• At least 5 half-lives since any agent causing androgen deprivation and current Testosterone of > 5nmol/L
• PSMA scan within 4 weeks of enrolment
• PSMA detected metastases either
a. 1-3 and suitable for SBRT (Lymph node &/or bone)
b. >3 but confined to pelvis and paraaortic regions
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
-• Any concurrent use of agents that reduce androgen production or block androgen action.
-• Active or prior documented significant autoimmune or inflammatory disorders
-• Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
30 subjects have been determined to give 80% power to detect clinically meaningful improvement in biochemical progression free survival

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
4/02/2019
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
30
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12617 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 25035 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 301192 0
Hospital
Name [1] 301192 0
Royal North Shore Hospital
Country [1] 301192 0
Australia
Primary sponsor type
Hospital
Name
Northern Sydney Local Health District
Address
199 Pacific Highway
ST LEONARDS NSW 2065
Country
Australia
Secondary sponsor category [1] 301007 0
None
Name [1] 301007 0
Address [1] 301007 0
Country [1] 301007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301932 0
Northern Sydney Local Health District Research Office
Ethics committee address [1] 301932 0
Ethics committee country [1] 301932 0
Australia
Date submitted for ethics approval [1] 301932 0
23/02/2018
Approval date [1] 301932 0
02/08/2018
Ethics approval number [1] 301932 0
RESP/18/49

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88606 0
A/Prof Alexander Guminski
Address 88606 0
Department of Medical Oncology
Royal North Shore Hospital
199 Pacific Hwy
ST LEONARDS NSW 2061
Country 88606 0
Australia
Phone 88606 0
+61 2 9463 1172
Fax 88606 0
+61 2 9463 1092
Email 88606 0
[email protected]
Contact person for public queries
Name 88607 0
Sally McCowatt
Address 88607 0
Department of Medical Oncology
Royal North Shore Hospital
199 Pacific Hwy
ST LEONARDS NSW 2061
Country 88607 0
Australia
Phone 88607 0
+61 2 9463 1181
Fax 88607 0
+61 2 9463 1092
Email 88607 0
[email protected]
Contact person for scientific queries
Name 88608 0
Alexander Guminski
Address 88608 0
Department of Medical Oncology
Royal North Shore Hospital
199 Pacific Hwy
ST LEONARDS NSW 2061
Country 88608 0
Australia
Phone 88608 0
+61 2 9463 1172
Fax 88608 0
+61 2 9463 1092
Email 88608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified Patient response and outcome data
De-identified Patient toxicity data
When will data be available (start and end dates)?
Starting 1st March 2019 to 1st March 2021
Available to whom?
Researchers who may wish to report outcomes from similar treatment and who have ethical approval to use shared data
Available for what types of analyses?
Analyses of patient outcomes including toxicity
How or where can data be obtained?
Password protected electronic exchange


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.