Exploration of Treatment Effect of Novel Hormone Therapy Combined with Local Treatment Based on PSMA PET/CT Evaluation in MHSCP Patients

NCT ID: NCT06832774

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-12-31

Brief 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 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. After 6 months of 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Novel hormone therapy

Group Type: ACTIVE_COMPARATOR

Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).

Intervention Type: 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.

Novel hormone therapy and Local treatment

Group Type: EXPERIMENTAL

Local treatment

Intervention Type: PROCEDURE

For bone lesions, radiotherapy or orthopedic surgery may be selected. For lymph node lesions, radiotherapy or high-energy focused ultrasound (HIFU) 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).

Intervention Type: 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.

Interventions

Local treatment

For bone lesions, radiotherapy or orthopedic surgery may be selected. For lymph node lesions, radiotherapy or high-energy focused ultrasound (HIFU) maybe selected. The specific treatment plan will be determined by the researcher and based on the patient's clinical condition.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male patients over the age of 18;

2. The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0, 1, or 2 points;

3. Expected lifespan >2 years;

4. 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;

5. Has not received any other treatment for prostate cancer before;

6. No significant organ dysfunction upon evaluation;

7. 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.

Exclusion Criteria

1. 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);

2. Prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components;

3. Severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study;

4. Currently participating in other clinical trials for prostate cancer;

5. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Han Bangmin

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Bangmin Han, Doctor

Role: CONTACT

hanbm@163.com

86-021-63240090

Other Identifiers

IIT2025-009

Identifier Type: -

Identifier Source: org_study_id