Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer

NCT07553780 | Recruiting

• 1 other identifier: KY20262013-F-1
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 9

Brief Summary

This prospective, multicenter study aims to evaluate the clinical utility of serial PSMA PET for therapy monitoring in patients with newly diagnosed clinically significant prostate cancer. Clinically significant prostate cancer is defined as Gleason score ≥7.Patients will undergo baseline PSMA PET/CT prior to any treatment. A second PSMA PET/CT will be performed either at PSA recurrence (PSA rise ≥2 ng/mL above nadir after radiotherapy or biochemical progression per PCWG3 criteria) or at a fixed time window of 12-24 months after treatment completion for those without biochemical recurrence. Primary Outcome: 1\. Absolute and relative change in SUVmax from baseline to follow-up PSMA PET, correlated with treatment response categories (complete response, partial response, stable disease, progressive disease) defined by a composite reference standard (PSA kinetics, conventional imaging, clinical outcomes). \[Time Frame: Baseline and follow-up (up to 24 months)\] Secondary Outcomes:

1. 1.Absolute and relative change in the number of PSMA-avid lesions (primary tumor, nodal, bone metastases) as a supportive exploratory endpoint.
2. 2.Proportion of patients with treatment strategy change following serial PSMA PET.
3. 3.Agreement between PSMA PET response (≥30% decrease in SUVmax) and PSA50 response (≥50% PSA decline) using Cohen's kappa.
4. 4.Agreement between PSMA PET response and PSA90 response (≥90% PSA decline).
5. 5.Prognostic value of baseline and follow-up PSMA PET parameters for progression-free survival (PFS).
6. 6.Prognostic value of baseline and follow-up PSMA PET parameters for time to castration resistance (ADT-treated patients only).
7. 7.Subgroup analyses by treatment type (radiotherapy, ADT, chemotherapy), baseline disease burden (oligometastatic vs. polymetastatic), and Gleason grade group (≤7 vs. ≥8).
8. 8.Inter-reader agreement for PSMA-avid lesion counts. \[Time Frame: Up to 2 years, except inter-reader agreement at baseline\]
9. 9.Newly diagnosed, histologically confirmed clinically significant prostate cancer with Gleason score ≥7.
10. 10.Planned curative-intent or systemic therapy.
11. 11.Baseline PSMA PET performed prior to any treatment.
12. 12.Age ≥18 years.
13. 13.Written informed consent.
14. 14.Prior prostate cancer treatment before baseline PSMA PET.
15. 15.Contraindication to PSMA PET imaging.
16. 16.Other active malignancy within past two years (excluding non-melanoma skin cancer).
17. 17.Unable to comply with follow-up schedule.

Conditions

High-risk Prostate Cancer; PSMA PET; Therapy Monitoring; Treatment Response

Keywords

Prostate Cancer; PSMA PET; Treatment Response; Therapy Monitoring; High-Risk

Outcome Measures

Primary Outcomes (1)

• Absolute and relative change in SUVmax from baseline to follow-up PSMA PET

  Description: SUVmax (maximum standardized uptake value) will be measured in the most intense PSMA-avid lesion (up to 5 lesions recorded; the highest value used). Absolute change (ΔSUVmax) and relative change (percentage) will be calculated. The correlation with treatment response categories (complete response, partial response, stable disease, progressive disease) defined by a composite reference standard (PSA kinetics, conventional imaging, clinical outcomes) will be assessed using Spearman correlation and linear mixed-effects models. Measurement tool and unit: PSMA PET/CT; unitless (SUVmax) and percentage (%).

  Baseline and follow-up (12-24 months post-treatment or at time of PSA recurrence); overall assessment up to 2 years.

Secondary Outcomes (8)

• Proportion of patients with treatment strategy change following serial PSMA PET

  Up to 2 years

• Absolute and relative change in number of PSMA-avid lesions (supportive endpoint)

  Baseline and follow-up (12-24 months or at PSA recurrence); overall up to 2 years.

• Agreement between PSMA PET response and PSA50 response

  Up to 2 years

• Agreement between PSMA PET response and PSA90 response

  Up to 2 years

• Association of PSMA PET parameters with progression-free survival (PFS)(exploratory)

  Up to 2 years

Study Arms (1)

Clinically Significant Prostate Cancer Cohort

A single cohort of 110 patients with newly diagnosed, treatment-naïve clinically significant prostate cancer (defined as Gleason score ≥7). All patients undergo baseline PSMA PET imaging prior to any treatment, followed by a second PSMA PET scan triggered by PSA recurrence (PSA ≥0.2 ng/mL after radical prostatectomy or ≥2 ng/mL above nadir after radiotherapy) or performed at 12-24 months after treatment completion if no recurrence occurs. Patients receive standard clinical treatments (radiotherapy, radical prostatectomy, ADT, or chemotherapy) as determined by their physicians. The cohort is used to evaluate the utility of serial PSMA PET for treatment response monitoring and its association with clinical outcomes.

Eligibility Criteria

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

Study Population

A consecutive series of approximately 110 patients (targeting 100 evaluable after 10% loss to follow-up) with newly diagnosed, histologically confirmed clinically significant prostate cancer (Gleason score ≥7), treatment-naïve, recruited from multiple centers. All patients undergo baseline PSMA PET/CT prior to any treatment. A second PSMA PET/CT is performed either at PSA recurrence (defined as PSA ≥0.2 ng/mL after radical prostatectomy or PSA rise ≥2 ng/mL above nadir after radiotherapy) or at 12-24 months after treatment completion for those without biochemical recurrence. Patients receive standard clinical treatments per physician discretion. This single cohort is used to evaluate serial PSMA PET for treatment response monitoring.

You may qualify if:

• Newly diagnosed, histologically confirmed prostate cancer with Gleason score ≥7 (clinically significant prostate cancer).
• Planned to receive curative-intent therapy (radical prostatectomy or radiotherapy) or systemic therapy (androgen deprivation therapy, chemotherapy, or combination).
• Undergo baseline PSMA PET/CT imaging prior to any prostate cancer-related treatment.
• Age ≥18 years.
• Willing and able to comply with the follow-up schedule, including the second PSMA PET/CT scan.
• Provide written informed consent.

You may not qualify if:

• Any prior prostate cancer treatment (including hormonal therapy, radiotherapy, chemotherapy, or surgery) before baseline PSMA PET/CT.
• Contraindications to PSMA PET/CT imaging (e.g., known severe allergic reaction to radiotracer components, inability to lie flat for the duration of the scan).
• Other active malignancy within the past two years, excluding non-melanoma skin cancer.
• Severe comorbidities or conditions that, in the opinion of the investigator, could interfere with study compliance or pose a significant risk to the patient.
• Unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Xijing Hospital: lead
• Air Force Military Medical University, China: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Yan'an University Affiliated Hospital: collaborator
• Weinan Central Hospital: collaborator
• The Second Affiliated Hospital of Shaanxi University of Chinese Medicine: collaborator
• LanZhou University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• General Hospital of Ningxia Medical University: collaborator

Study Sites (9)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

RECRUITING

Qinghai University Affiliated Hospital

Xining, Qinghai, China

RECRUITING

Weinan Central Hospital

Weinan, Shaanxi, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

RECRUITING

Xijing 986 Hospital

Xi'an, Shaanxi, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, China

RECRUITING

Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Jianhua Jiao, MD.

CONTACT

+86 18700919857; 1531769428@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 28, 2026
• Study Start: March 7, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)