ProsTIC Registry of Men Treated With PSMA Theranostics

Prostate specific antigen-response rate (PSA-RR) defined as the proportion of participants with a PSA reduction of ≥ 50 percent from baseline.

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

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.

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.

OS is defined as the time from treatment initiation to the date of death due to any cause.

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.

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.

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

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

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.

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

Measurement of prognostic and predictive biomarkers. Alterations in whole blood ribonucleic acid (RNA) androgen receptor splice variants

Measurement of prognostic and predictive biomarkers. Alterations in whole blood ribonucleic acid (RNA) TMPRSS2:ERG fusion