A Phase 3 interventional study of 68Ga-PSMA-11 and PET/CT or PET/MRI in Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer and BCR Prostate Carcinoma, sponsored by Telix Pharmaceuticals (Innovations) Pty Limited. Recruiting at 8 sites in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Telix Pharmaceuticals (Innovations) Pty Limited · Phase 3, Interventional, and Diagnostic
This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 110 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Telix Pharmaceuticals (Innovations) Pty Limited is the lead sponsor of 20 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).
Exclusion Criteria:
111 \~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes. After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead.
Drug: 68Ga-PSMA-11 · Other: PET/CT or PET/MRI
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
Also known as: Illucix, gallium Ga 68 Gozetotide
PET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11
Also known as: Imaging by PET
Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up.
The PPV \[PPV (%) = TP\* /(TP + FP\*\*)\] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative).
Time frame: 12 months
Incidence of adverse events
Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events
Time frame: 3 days
Clinical management in biochemical recurrence patients.
The impact of 68Ga-PSMA-11 PET/CT or PET/MRI on clinical management in biochemical recurrence patients will be assessed through the completion of Medical Management Questionnaires completed prior to and after 68Ga-PSMA-11 PET/CT or PET/MRI.
Time frame: 3 days
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Telix Pharmaceuticals (Innovations) Pty Limited