Biochemical Recurrence of Malignant Neoplasm of ProstatePhase 3NCT05847348
68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
A Phase 3 study testing 68Ga-PSMA-11 and PET/CT or PET/MRI in people with Biochemical Recurrence of Malignant Neoplasm of Prostate and Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer, BCR Prostate Carcinoma
- What is being tested?
- 68Ga-PSMA-11 and PET/CT or PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesChina
- Study dates
- 19 Jul 2023to 30 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are able to understand and provide written informed consent document.
- Are Chinese males aged ≥ 18 years.
- 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).
- Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
- Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
- Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
- Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
- Are willing and able to comply with scheduled
Who cannot join
- Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
- Are participating or plan to participate in any drug or device clinical study during the study period.
- Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
- Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
- Have prior history of salivary gland disease or Paget's disease.
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- Have a history of fracture and anemia within the last year.
- Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
- Is deemed not suitable for participating in this trial in the opinion of the investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking University First Hospital
Beijing
Principal Investigator, 0086-010-83572732, info@telixpharma.com
Yan Fan
- Recruiting
Xiangya Hospital Central South University
Changsha
Principal Investigator, 0086-0731-89752051, info@telixpharma.com
Shuo Hu
- Recruiting
Nanfang Hospital Southern Medical University
Guangzhou
Principal Investigator, 0086-020-62783210, info@telixpharma.com
Wanlong Tan
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Principal Investigator, 0086-021-64175590-88900, info@telixpharma.com
Shaoli Song
- Recruiting
West China Hospital of Sichuan University
Sichuan
Principal Investigator, 0086-028-85423532, info@telixpharma.com
Lin Li
- Recruiting
Wuhan Union Hospital
Wuhan
Principal Investigator, 0086-027-83692633, info@telixpharma.com
Xiaoli Lan, PhD
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Principal Investigator, 0086-027-67813181, info@telixpharma.com
Yong He
- Recruiting
Affiliated Hosptial of Jiangnan University
Wuxi
Principal Investigator, 0086-0510-68089397, info@telixpharma.com
ChunJing Yu
About this study
Official title: A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer
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.
- Conditions
- Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer, BCR Prostate Carcinoma
- Being tested
- 68Ga-PSMA-11, PET/CT or PET/MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-11Drug
Also called Illucix, gallium Ga 68 Gozetotide
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
PET/CT or PET/MRIOther
Also called Imaging by PET
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment (68Ga-PSMA-11) | Experimental | 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. Receives: Drug: 68Ga-PSMA-11; Other: PET/CT or PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start19 Jul 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical Recurrence of Malignant Neoplasm of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847348
- Sponsor's protocol ID
- 68Ga-PSMA-11-001
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT05847348
- Acronym / sponsor ID
- 68Ga-PSMA-11-001
- Conditions
- Biochemical Recurrence of Malignant Neoplasm of Prostate, Prostate Cancer, BCR Prostate Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Treatment (68Ga-PSMA-11) | Experimental | Drug: 68Ga-PSMA-11, Other: PET/CT or PET/MRI111 ~ 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are able to understand and provide written informed consent document.
- Are Chinese males aged ≥ 18 years.
- 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).
- Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
- Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
Key exclusion criteria (9 listed)
- Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
- Are participating or plan to participate in any drug or device clinical study during the study period.
- Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
- Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-PSMA-11Also: Illucix, gallium Ga 68 GozetotideA single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes | Drug | Treatment (68Ga-PSMA-11) |
| PET/CT or PET/MRIAlso: Imaging by PETPET/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 | Other | Treatment (68Ga-PSMA-11) |
Primary outcome
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.
Time frame: 12 months
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).
2 secondary outcomes
Incidence of adverse events
Time frame: 3 days
Clinical management in biochemical recurrence patients.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-PSMA-11 and PET/CT or PET/MRI in people with Biochemical Recurrence of Malignant Neoplasm of Prostate and Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.