ProsTIC Registry of Men Treated With PSMA Theranostics

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769817
• Other study ID #: PMC 20/164
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: Elizabeth Medhurst
• Phone: +61 3 8559 8617
• Email: ProsTIC[@]petermac.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prognostic and predictive value of baseline PET/CT	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.
Other	Prognostic value of 12 week restaging PSMA and FDG PET/CT	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.
Other	Histopathology parameters	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.
Other	Tumour DNA ± tumour tissue	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.
Other	Whole blood RNA (androgen receptor splice variants)	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.
Other	Whole blood RNA (TMPRSS2:ERG fusion gene)	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.
Primary	PSA-RR	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	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	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.
Secondary	Radiographic progression-free survival (rPFS)	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).
Secondary	PSA progression free survival (PSA-PFS)	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).
Secondary	Overall survival (OS)	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.
Secondary	EORTC QLQ-C30	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).
Secondary	PPI	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).