ProsTIC Registry of Men Treated With PSMA Theranostics

August 29, 2023 updated by: Peter MacCallum Cancer Centre, Australia

Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Prospective Patient Registry of Men Treated With PSMA Theranostics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the registry is to collect data of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium 177 (177Lu)-PSMA outside of a clinical trial to assess "real world" anti-tumour utility. The primary objective is to assess prostate specific antigen (PSA) response rate to 177Lu-PSMA in men with mCRPC.

Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.

The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Hofman, MBBS, FRACP, FAANMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men with mCRPC who have progressed after novel anti-androgen therapy and taxane chemotherapy (unless unfit and symptomatic).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA-RR
Time Frame: From baseline through to progression or death until registry completion (approx. 5 years).
Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.
From baseline through to progression or death until registry completion (approx. 5 years).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From date of treatment to 12 weeks after completing study treatment.
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
From date of treatment to 12 weeks after completing study treatment.
Radiographic progression-free survival (rPFS)
Time Frame: From date of treatment through to progression or death until registry completion (approx. 5 years).
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.
From date of treatment through to progression or death until registry completion (approx. 5 years).
PSA progression free survival (PSA-PFS)
Time Frame: From date of treatment through to progression or death until registry completion (approx. 5 years).
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.
From date of treatment through to progression or death until registry completion (approx. 5 years).
Overall survival (OS)
Time Frame: From date of treatment, up until 18 months after the last patient commences treatment.
OS is defined as the time from treatment initiation to the date of death due to any cause.
From date of treatment, up until 18 months after the last patient commences treatment.
EORTC QLQ-C30
Time Frame: From baseline through to progression or death until registry completion (approx. 5 years).

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.
From baseline through to progression or death until registry completion (approx. 5 years).
PPI
Time Frame: From baseline through to progression or death until registry completion (approx. 5 years).
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.
From baseline through to progression or death until registry completion (approx. 5 years).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic and predictive value of baseline PET/CT
Time Frame: Baseline PSMA and FDG PET/CT within 3 months of 177Lu-PSMA therapy.
PET-derived parameters including molecular tumour volume parameters (volume, SUVmax, SUVmean) and other parameters including radiomics from PET, CT, post therapy SPECT/CT or bone scans using data-characterisation algorithms will be assessed
Baseline PSMA and FDG PET/CT within 3 months of 177Lu-PSMA therapy.
Prognostic value of 12 week restaging PSMA and FDG PET/CT
Time Frame: 12 weeks after first cycle of 177Lu-PSMA therapy.
PET-derived parameters including molecular tumour volume parameters (volume, SUVmax, SUVmean) and other parameters including radiomics from PET, CT, post therapy SPECT/CT or bone scans using data-characterisation algorithms will be assessed
12 weeks after first cycle of 177Lu-PSMA therapy.
Histopathology parameters
Time Frame: At baseline, 12 weeks post treatment and date of progression.
Histological grading of adenocarcinoma of the prostate (obtained via biopsy) using the International Society of Urological Pathology (ISUP) modified Gleason Grades. The cells identified are given a grade number from 1 to 5, depending on the abnormality of the cells, 1 being the lowest, 5 the highest. The grades of the two most common patterns are added together to give a score from 2 to 10. The higher the score, the more aggressive and fast-growing the cancer.
At baseline, 12 weeks post treatment and date of progression.
Tumour DNA ± tumour tissue
Time Frame: At baseline, 12 weeks post treatment and date of progression.
Measurement of prognostic and predictive biomarkers (Circulating tumour deoxyribonucleic acid (DNA) ± tumour tissue (DNA repair genes, tumour suppressor genes, androgen receptor) associated with treatment outcome and response
At baseline, 12 weeks post treatment and date of progression.
Whole blood RNA (androgen receptor splice variants)
Time Frame: At baseline, 12 weeks post treatment and date of progression.
Measurement of prognostic and predictive biomarkers. Alterations in whole blood ribonucleic acid (RNA) androgen receptor splice variants
At baseline, 12 weeks post treatment and date of progression.
Whole blood RNA (TMPRSS2:ERG fusion gene)
Time Frame: At baseline, 12 weeks post treatment and date of progression.
Measurement of prognostic and predictive biomarkers. Alterations in whole blood ribonucleic acid (RNA) TMPRSS2:ERG fusion
At baseline, 12 weeks post treatment and date of progression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 6, 2020

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC 20/164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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