Prostate Specific Membrane Antigen Positive Metastatic Prostate CancerNCT06201741
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
A study testing [131I]/[18F]/[68Ga]ZT-111 in people with Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer, run by Huashan Hospital at 1 site in China.
Trial summary
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the [131I]/[18F]/[68Ga]ZT-111 in patients with PSMA positive metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
- What is being tested?
- [131I]/[18F]/[68Ga]ZT-111
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old.
- Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
- Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
- Willing and able to comply with all aspects of this study.
Who cannot join
- Severe hepatic or renal impairment.
- History of major surgery within the last month.
- Participation in another concurrent clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai
Yihui Guan, MD, 13764308300 ext. +86, guanyihui@hotmail.com
About this study
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the [131I]/[18F]/[68Ga]ZT-111 in patients with PSMA positive metastatic prostate cancer.
- Being tested
- [131I]/[18F]/[68Ga]ZT-111
- Keywords
- PSMA positive metastatic prostate cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[131I]/[18F]/[68Ga]ZT-111Radiation
[131I]/[18F]/[68Ga]ZT-111, single dose
| Study group | Role | What they receive |
|---|---|---|
| [131I]/[18F]/[68Ga]ZT-111 | Experimental | [131I]/[18F]/[68Ga]ZT-111, single dose Receives: Radiation: [131I]/[18F]/[68Ga]ZT-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry
Whole body and organ uptake activity
Measured: About 24hours from time of injection
Secondary outcomes (1)
Incidence and severity of adverse events
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Measured: From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start27 Dec 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Specific Membrane Antigen Positive Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201741
- Sponsor's protocol ID
- KY2023-1018
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06201741
- Acronym / sponsor ID
- KY2023-1018
- Keywords
- PSMA positive metastatic prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Jan 2024 (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 study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the [131I]/[18F]/[68Ga]ZT-111 in patients with PSMA positive metastatic prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [131I]/[18F]/[68Ga]ZT-111 | Experimental | Radiation: [131I]/[18F]/[68Ga]ZT-111[131I]/[18F]/[68Ga]ZT-111, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years old.
- Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
- Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
- Willing and able to comply with all aspects of this study.
Key exclusion criteria (3 listed)
- Severe hepatic or renal impairment.
- History of major surgery within the last month.
- Participation in another concurrent clinical trial.
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 |
|---|---|---|
| [131I]/[18F]/[68Ga]ZT-111[131I]/[18F]/[68Ga]ZT-111, single dose | Radiation | [131I]/[18F]/[68Ga]ZT-111 |
Primary outcome
Dosimetry
Time frame: About 24hours from time of injection
Whole body and organ uptake activity
1 secondary outcome
Incidence and severity of adverse events
Time frame: From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
Active, not recruitingPhase 1
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
Prostate Cancer
RecruitingPhase 3
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Oligometastatic Prostate Cancer (OMPC)
Active, not recruitingPhase 2
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC
Metastatic Castration Resistant Prostate Cancer (mCRPC)
RecruitingPhase 3
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
Metastatic Castration-resistant Prostate Cancer
RecruitingPhase 1/2
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [131I]/[18F]/[68Ga]ZT-111 in people with Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer, run by Huashan Hospital at 1 site 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 4 inclusion and 3 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Yihui Guan, MD (+86 13764308300, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry (time frame: About 24hours from time of injection). 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 25 Jan 2024.