Prostate Cancer Metastatic DiseasePhase 2NCT06832774
Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients
A Phase 2 study testing Local treatment and Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). in people with Prostate Cancer Metastatic Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease
- What is being tested?
- Local treatment and Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2028
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients over the age of 18;
- The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0, 1, or 2 points;
- Expected lifespan >2 years;
- All newly diagnosed patients with metastatic prostate cancer (mHSPC, metastatic hormone sensitive prostate cancer) diagnosed by PSMA PET/CT, and still present active lesions on PSMA PET/CT after receiving new endocrine therapy;
- Has not received any other treatment for prostate cancer before;
- No significant organ dysfunction upon evaluation;
- Agreed to sign the written consent form for this study, indicating a comprehensive understanding of the purpose and process of this study, and willingness to participate in this study.
Who cannot join
- A medical history of any other active malignant tumor within 2 years (excluding fully treated basal cell or squamous cell skin cancer, superficial bladder cancer or any other cancer in situ that is currently in complete remission);
- Prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components;
- Severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study;
- Currently participating in other clinical trials for prostate cancer;
- According to the researcher's judgment, there are conditions that are not in line with the best interests of the subjects participating in the study, or may hinder, limit, or interfere with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Han Professor, 86-63240090, hanbm@163.com
About this study
At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical situation. However, it is still unclear how to develop more specific and individualized treatment plans for mHSPC patients. On the other hand, prostate-specific membrane antigen (PSMA) which is highly specifically expressed in prostate epithelial cells has been widely used as a PET/CT target for the diagnosis and staging of prostate cancer. However, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. Therefore, this study intends to include patients diagnosed with mHSPC by PSMA PET/CT. The patients received no prior treatment for prostate cancer or ADT plus NHT therapy only. After 8 months of ADT plus NHT, PSMA PET/CT will be re-evaluated and patients with remaining active lesions on PSMA PET/CT will be included for randomization. The aim of this study is to explore the effect of NHT combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on PSMA PET/CT after NHT, providing new insights into the treatment of mHSCP patients.
- Conditions
- Prostate Cancer Metastatic Disease
- Being tested
- Local treatment, Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local treatmentProcedure or surgery
For bone lesions, radiotherapy or orthopedic surgery may be selected. For lymph node lesions, radiotherapy, high-energy focused ultrasound (HIFU) or other available options maybe selected. The specific treatment plan will be determined by the researcher and based on the patient's clinical condition.
Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).Drug
The intervention contains gonadotropin releasing hormone analog (GnRHa) and novel hormone therapy. For GnRHa, there are 3 options available. 1. "Leuprorelin"/"Prostap" or "Staladex". 2. "Goserelin"/"Zoladex". 3. "Triptorelin" /"LiverTox". For novel hormone therapy, there are also 3 options available. 1. "Abiraterone"/ "ZYTIGA®". 2. "Apalutamide"/"ERLEADA®". 3. "Rezvilutamide"/"ARIANE®". The specific treatment plan will be designed according to patients' clinical conditions based on EAU guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Novel hormone therapy | Active comparator | Not described Receives: Drug: Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). |
| Novel hormone therapy and Local treatment | Experimental | Not described Receives: Procedure: Local treatment; Drug: Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival, PFS
Progression includes biochemical progression, clinical progression, and imaging progression. The definition of biochemical progression is a PSA increase of more than 25% and an absolute increase of 2ng/ml compared above baseline or nadir. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary and metastatic lesions of prostate cancer. The definition of imaging progression is the appearance of any new metastatic lesion in CT/MR/PET/CT scan. When one of the above criteria is met, it can be considered as disease progression.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Bangmin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832774
- Sponsor's protocol ID
- IIT2025-009
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients
- ClinicalTrials.gov ID
- NCT06832774
- Acronym / sponsor ID
- IIT2025-009
- Conditions
- Prostate Cancer Metastatic Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Feb 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.
At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical situation. However, it is still unclear how to develop more specific and individualized treatment plans for mHSPC patients. On the other hand, prostate-specific membrane antigen (PSMA) which is highly specifically expressed in prostate epithelial cells has been widely used as a PET/CT target for the diagnosis and staging of prostate cancer. However, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. Therefore, this study intends to include patients diagnosed with mHSPC by PSMA PET/CT. The patients received no prior treatment for prostate cancer or ADT plus NHT therapy only. After 8 months of ADT plus NHT, PSMA PET/CT will be re-evaluated and patients with remaining active lesions on PSMA PET/CT will be included for randomization. The aim of this study is to explore the effect of NHT combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on PSMA PET/CT after NHT, providing new insights into the treatment of mHSCP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel hormone therapy | Active comparator | Drug: Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). |
| Novel hormone therapy and Local treatment | Experimental | Procedure: Local treatment, Drug: Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients over the age of 18;
- The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0, 1, or 2 points;
- Expected lifespan >2 years;
- All newly diagnosed patients with metastatic prostate cancer (mHSPC, metastatic hormone sensitive prostate cancer) diagnosed by PSMA PET/CT, and still present active lesions on PSMA PET/CT after receiving new endocrine therapy;
- Has not received any other treatment for prostate cancer before;
Key exclusion criteria (5 listed)
- A medical history of any other active malignant tumor within 2 years (excluding fully treated basal cell or squamous cell skin cancer, superficial bladder cancer or any other cancer in situ that is currently in complete remission);
- Prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components;
- Severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study;
- Currently participating in other clinical trials for prostate cancer;
- According to the researcher's judgment, there are conditions that are not in line with the best interests of the subjects participating in the study, or may hinder, limit, or interfere with the study protocol.
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 |
|---|---|---|
| Local treatmentFor bone lesions, radiotherapy or orthopedic surgery may be selected. For lymph node lesions, radiotherapy, high-energy focused ultrasound (HIFU) or other available options maybe selected. The specific treatment plan will be determined by the researcher and based on the patient's clinical condition. | Procedure or surgery | Novel hormone therapy and Local treatment |
| Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).The intervention contains gonadotropin releasing hormone analog (GnRHa) and novel hormone therapy. For GnRHa, there are 3 options available. 1. "Leuprorelin"/"Prostap" or "Staladex". 2. "Goserelin"/"Zoladex". 3. "Triptorelin" /"LiverTox". For novel hormone therapy, there are also 3 options available. 1. "Abiraterone"/ "ZYTIGA®". 2. "Apalutamide"/"ERLEADA®". 3. "Rezvilutamide"/"ARIANE®". The specific treatment plan will be designed according to patients' clinical conditions based on EAU guidelines. | Drug | Novel hormone therapy, Novel hormone therapy and Local treatment |
Primary outcome
Progression free survival, PFS
Time frame: From enrollment to the end of treatment at 12 weeks
Progression includes biochemical progression, clinical progression, and imaging progression. The definition of biochemical progression is a PSA increase of more than 25% and an absolute increase of 2ng/ml compared above baseline or nadir. The definition of clinical progression is the emergence of any new clinical symptoms related to the primary and metastatic lesions of prostate cancer. The definition of imaging progression is the appearance of any new metastatic lesion in CT/MR/PET/CT scan. When one of the above criteria is met, it can be considered as disease progression.
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 25 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Local treatment and Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide). in people with Prostate Cancer Metastatic Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Bangmin Han, Doctor (86-021-63240090, hanbm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival, PFS (time frame: From enrollment to the end of treatment at 12 weeks). 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 Mar 2026.