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

NCT06387238 | Not Yet Recruiting

• 1 other identifier: PSMA-mHSPC
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• rPFS

  radiological progression free survival

  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

  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

  From date of enrollment treatment until the date of death from any cause, assessed up to 12 months.

Study Arms (1)

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.

Diagnostic Test: PSMA PET/CT

Interventions

PSMA PET/CT DIAGNOSTIC_TEST

pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy.

mHSPC-PSMA

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Central Study Contacts

Xuhe Liao, Dr

CONTACT

0086-10-83575252; liaoxuhe@bjmu.edu.cn

Hongwei Sun, Dr

CONTACT

0086-10-83575252; lxhxixi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share