Prostate AdenocarcinomaNCT06387238
Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer
A study testing PSMA PET/CT in people with Prostate Adenocarcinoma, run by Peking University First Hospital.
Trial summary
1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis. 2. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- PSMA PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Jun 2026
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer patients confirmed to have metastasis by PSMA PET/CT before new endocrine therapy.
- Those who have not undergone androgen deprivation treatment in the past, or have currently received androgen deprivation treatment for no more than 120 days without progress, or have received androgen deprivation treatment in the past (treatment time less than 24 months and no progress within 12 months after completion).
- Patients with KPS score ≥ 50 (ECOG/WHO equivalent).
- Patient age>18 years old.
Who cannot join
- Patients who cannot understand and voluntarily participate in this trial, donnot sign an informed consent form, and aren't able to cooperate independently in completing the examination.
Trial locations and contacts
No sites are listed yet.
About this study
- Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.
- Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis.
Read the detailed description
- Construction of PSMA PET whole-body tumor burden classification:
- Assessment of whole-body tumor burden on PSMA PET/CT images of mHSPC patients before new endocrine therapy.
- PSMA PET/CT imaging evaluation of treatment response of the first three months after start of new endocrine therapy.
- Based on the response results, the optimal threshold for whole-body tumor burden is obtained through ROC curve analysis, and a preliminary classification of whole-body tumor burden is obtained.
Verification 1: Follow up preliminary verification/improvement of this subtype Verification 2: External verification, reverifying the predictive performance of typing through the verification cohort.
- Construction of multivariable predictive model for mHSPC patients with novel endocrine therapy:
- Molecular imaging parameter measurement and collection of PSMA PET/CT images of mHSPC patients of 3 months after the start of new endocrine therapy.
- Complete pre-treatment genetic testing, dynamic evaluation of serum PSA before and after treatment, and collection of clinical and pathological information.
- Based on follow-up results, construct a multi factor model, screen significant factors, and achieve a predictive model for novel endocrine therapy in mHSPC patients Verification: External verification, verifying the predictive performance of the model through the verification cohort.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- PSMA PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CTDiagnostic test
pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| mHSPC-PSMA | Experimental | Patients with mHSPC who will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. Receives: Diagnostic Test: PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
rPFS
radiological progression free survival
Measured: From date of enrollment treatment until the date of first documented progression confirmed by radiological examinations or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary outcomes (2)
PSA-PFS
PSA progression free survival
Measured: From date of enrollment treatment until the date of first documented progression confirmed by blood PSA tests or date of death from any cause, whichever came first, assessed up to 12 months.
OS
overall survival
Measured: From date of enrollment treatment until the date of death from any cause, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Model description
- Patients With Metastatic Hormone Sensitive Prostate Cancer, will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387238
- Sponsor's protocol ID
- PSMA-mHSPC
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT06387238
- Acronym / sponsor ID
- PSMA-mHSPC
- Conditions
- Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Apr 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.
- Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.
- Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis.
Detailed description
- Construction of PSMA PET whole-body tumor burden classification:
- Assessment of whole-body tumor burden on PSMA PET/CT images of mHSPC patients before new endocrine therapy.
- PSMA PET/CT imaging evaluation of treatment response of the first three months after start of new endocrine therapy.
- Based on the response results, the optimal threshold for whole-body tumor burden is obtained through ROC curve analysis, and a preliminary classification of whole-body tumor burden is obtained.
Verification 1: Follow up preliminary verification/improvement of this subtype Verification 2: External verification, reverifying the predictive performance of typing through the verification cohort.
- Construction of multivariable predictive model for mHSPC patients with novel endocrine therapy:
- Molecular imaging parameter measurement and collection of PSMA PET/CT images of mHSPC patients of 3 months after the start of new endocrine therapy.
- Complete pre-treatment genetic testing, dynamic evaluation of serum PSA before and after treatment, and collection of clinical and pathological information.
- Based on follow-up results, construct a multi factor model, screen significant factors, and achieve a predictive model for novel endocrine therapy in mHSPC patients Verification: External verification, verifying the predictive performance of the model through the verification cohort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients With Metastatic Hormone Sensitive Prostate Cancer, will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy.
| Arm | Type | Receives |
|---|---|---|
| mHSPC-PSMA | Experimental | Diagnostic Test: PSMA PET/CTPatients with mHSPC who will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prostate cancer patients confirmed to have metastasis by PSMA PET/CT before new endocrine therapy.
Key exclusion criteria (1 listed)
- Patients who cannot understand and voluntarily participate in this trial, donnot sign an informed consent form, and aren't able to cooperate independently in completing the examination.
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 |
|---|---|---|
| PSMA PET/CTpre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. | Diagnostic test | mHSPC-PSMA |
Primary outcome
rPFS
Time frame: From date of enrollment treatment until the date of first documented progression confirmed by radiological examinations or date of death from any cause, whichever came first, assessed up to 12 months.
radiological progression free survival
2 secondary outcomes
PSA-PFS
Time frame: From date of enrollment treatment until the date of first documented progression confirmed by blood PSA tests or date of death from any cause, whichever came first, assessed up to 12 months.
OS
Time frame: From date of enrollment treatment until the date of death from any cause, assessed up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET/CT in people with Prostate Adenocarcinoma, run by Peking University First Hospital.
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 1 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Xuhe Liao, Dr (0086-10-83575252, liaoxuhe@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rPFS (time frame: From date of enrollment treatment until the date of first documented progression confirmed by radiological examinations or date of death from any cause, whichever came first, assessed up to 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 29 Apr 2024.