Metastatic Prostate Cancer (mPC)Early Phase 1NCT06864572
[68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer
A Early Phase 1 study testing P17-079, P16-093, or P15-041 PET/CT in people with Metastatic Prostate Cancer (mPC), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Preclinical studies have confirmed that [68Ga]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables [68Ga]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer (mPC)
- What is being tested?
- P17-079, P16-093, or P15-041 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged 18-85 years, expected survival ≥12 weeks.
- Patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria.
- At least one measurable target lesion was present according to RECIST1.1 criteria.
- Obtain written informed consent and be able to follow up
Who cannot join
- Severe abnormal liver and kidney function
- Fertile subjects will need to use effective contraception during the study
- Unable to lie flat for half an hour
- Refused to join this clinical investigator
- Suffering from claustrophobia or other mental illness
- Other conditions deemed unsuitable for participation in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Application of Dual-target Imaging Agent [68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer
Preclinical studies have confirmed that [68Ga]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables [68Ga]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. It is a potential "killing two birds with one stone" imaging agent. At this stage, the clinical study of [68Ga]Ga-P17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.
- Conditions
- Metastatic Prostate Cancer (mPC)
- Being tested
- P17-079, P16-093, or P15-041 PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P17-079, P16-093, or P15-041 PET/CTDiagnostic test
P17-079, P16-093, or P15-041 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| P17-079+P16-093 | Experimental | Not described Receives: Diagnostic Test: P17-079, P16-093, or P15-041 PET/CT |
| P17-079+P15-041 | Experimental | Not described Receives: Diagnostic Test: P17-079, P16-093, or P15-041 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
measured by PET/CT
Measured: 0-180 min post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate Cancer (mPC)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864572
- Sponsor's protocol ID
- PekingUMCH-NM-079
- Status last verified
- Sep 2024
- First submitted
- 19 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Dual-target Imaging Agent [68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06864572
- Acronym / sponsor ID
- PekingUMCH-NM-079
- Conditions
- Metastatic Prostate Cancer (mPC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Mar 2025 (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.
Preclinical studies have confirmed that [68Ga]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables [68Ga]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. It is a potential "killing two birds with one stone" imaging agent. At this stage, the clinical study of [68Ga]Ga-P17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P17-079+P16-093 | Experimental | Diagnostic Test: P17-079, P16-093, or P15-041 PET/CT |
| P17-079+P15-041 | Experimental | Diagnostic Test: P17-079, P16-093, or P15-041 PET/CT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male aged 18-85 years, expected survival ≥12 weeks.
- Patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria.
- At least one measurable target lesion was present according to RECIST1.1 criteria.
- Obtain written informed consent and be able to follow up
Key exclusion criteria (6 listed)
- Severe abnormal liver and kidney function
- Fertile subjects will need to use effective contraception during the study
- Unable to lie flat for half an hour
- Refused to join this clinical investigator
- Suffering from claustrophobia or other mental illness
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 |
|---|---|---|
| P17-079, P16-093, or P15-041 PET/CTP17-079, P16-093, or P15-041 PET/CT | Diagnostic test | P17-079+P15-041, P17-079+P16-093 |
Primary outcome
SUV
Time frame: 0-180 min post-injection
measured by PET/CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Prostate Cancer (mPC)
Not yet recruitingPhase 2
[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)
Metastatic Prostate Cancer, Prostate Cancer
RecruitingObservational study
Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration
Metastatic Prostate Cancer (mPC)
RecruitingObservational study
European Registry of Next Generation Imaging in Advanced Prostate Cancer
Prostate Cancer, Advanced Prostate Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing P17-079, P16-093, or P15-041 PET/CT in people with Metastatic Prostate Cancer (mPC), run by Peking Union Medical College 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 6 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: enrolling by invitation, as of the sponsor's last update on 7 Mar 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 0-180 min post-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 7 Mar 2025.