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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04769817




Registration number
NCT04769817
Ethics application status
Date submitted
6/09/2020
Date registered
25/02/2021

Titles & IDs
Public title
ProsTIC Registry of Men Treated With PSMA Theranostics
Scientific title
Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
Secondary ID [1] 0 0
PMC 20/164
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - 177Lu-PSMA

Other interventions: 177Lu-PSMA
Lu-PSMA will be administered as a standard-of-care procedure following assessment of suitability by a nuclear medicine physician and managed in close collaboration with the patient's medical oncologist.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PSA-RR
Timepoint [1] 0 0
From baseline through to progression or death until registry completion (approx. 5 years).
Secondary outcome [1] 0 0
Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Timepoint [1] 0 0
From date of treatment to 12 weeks after completing study treatment.
Secondary outcome [2] 0 0
Radiographic progression-free survival (rPFS)
Timepoint [2] 0 0
From date of treatment through to progression or death until registry completion (approx. 5 years).
Secondary outcome [3] 0 0
PSA progression free survival (PSA-PFS)
Timepoint [3] 0 0
From date of treatment through to progression or death until registry completion (approx. 5 years).
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
From date of treatment, up until 18 months after the last patient commences treatment.
Secondary outcome [5] 0 0
EORTC QLQ-C30
Timepoint [5] 0 0
From baseline through to progression or death until registry completion (approx. 5 years).
Secondary outcome [6] 0 0
PPI
Timepoint [6] 0 0
From baseline through to progression or death until registry completion (approx. 5 years).

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Diagnosis of mCRPC
2. Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
3. Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy
4. Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elizabeth Medhurst
Address 0 0
Country 0 0
Phone 0 0
+61 3 8559 8617
Fax 0 0
Email 0 0
ProsTIC@petermac.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04769817