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

NCT06832774 | Recruiting Phase 2

• 1 other identifier: IIT2025-009
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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).

Interventions

Local treatment PROCEDURE

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.

Novel hormone therapy and Local treatment

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.

Novel hormone therapy; Novel hormone therapy and Local treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone; abiraterone; apalutamide

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Bangmin Han, Doctor

CONTACT

86-021-63240090; hanbm@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 18, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)