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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04769817
Registration number
NCT04769817
Ethics application status
Date submitted
6/09/2020
Date registered
25/02/2021
Date last updated
31/08/2023
Titles & IDs
Public title
ProsTIC Registry of Men Treated With PSMA Theranostics
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Scientific title
Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics
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Secondary ID [1]
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PMC 20/164
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Metastatic Castration-resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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PSA-RR
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Assessment method [1]
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Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of = 50 percent from baseline.
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Timepoint [1]
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From baseline through to progression or death until registry completion (approx. 5 years).
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Secondary outcome [1]
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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
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Assessment method [1]
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Safety of the combination will be measured by selected AEs and SAEs; only grade 3 or greater AEs related to 177Lu-PSMA with the exception of lymphopenia and fatigue or any grade 1-2 AEs that have not previously been reported with 177Lu-PSMA
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Timepoint [1]
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From date of treatment to 12 weeks after completing study treatment.
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Secondary outcome [2]
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Radiographic progression-free survival (rPFS)
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Assessment method [2]
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rPFS is defined as the time from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the investigator per response evaluation criteria in solid tumors (RECIST1.1) for soft tissue and prostate cancer working group three (PCWG3) for bone lesions.
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Timepoint [2]
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From date of treatment through to progression or death until registry completion (approx. 5 years).
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Secondary outcome [3]
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PSA progression free survival (PSA-PFS)
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Assessment method [3]
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PSA-PFS is defined as the time from treatment initiation to the date of PSA progression per PCWG3 or death due to any cause, whichever occurs first. The date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2ng/mL or more from the nadir is documented. For patients who have an initial PSA decline during treatment, this must be confirmed by a second value 3 or more weeks later.
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Timepoint [3]
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From date of treatment through to progression or death until registry completion (approx. 5 years).
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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OS is defined as the time from treatment initiation to the date of death due to any cause.
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Timepoint [4]
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From date of treatment, up until 18 months after the last patient commences treatment.
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Secondary outcome [5]
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EORTC QLQ-C30
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Assessment method [5]
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The European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and quality-of-life scale. The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), as well as the perceived financial impact of the disease and treatment.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [5]
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From baseline through to progression or death until registry completion (approx. 5 years).
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Secondary outcome [6]
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PPI
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Assessment method [6]
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Pain is measured using the McGill-Melzack Present Pain Intensity scale (PPI) Pain Response is defined for patients with a baseline PPI score of =2 or a baseline analgesic score of =10 points, as: (i) a PPI score reduction of =2 points from baseline with no increase in analgesic score; and/or, (ii) a decrease of = 50 percent in analgesic score with no increase PPI.
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Timepoint [6]
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From baseline through to progression or death until registry completion (approx. 5 years).
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
350
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a descriptive, observational, prospective, open-ended, registry utilising electronic
data capture to collect information on the outcomes of men treated with prostate
specific-membrane antigen (PSMA) theranostics.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04769817
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Elizabeth Medhurst
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Address
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Country
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Phone
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+61 3 8559 8617
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04769817
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