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Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer

Recruitingn/aAges 18 Years - anyMaleXijing Hospital
NCT07553780 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, cl

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Newly diagnosed, histologically confirmed prostate cancer with Gleason score ≥7 (clinically significant prostate cancer). 2. Planned to receive curative-intent therapy (radical prostatectomy or radiotherapy) or systemic therapy (androgen deprivation therapy, chemotherapy, or combination). 3. Undergo baseline PSMA PET/CT imaging prior to any prostate cancer-related treatment. 4. Age ≥18 years. 5. Willing and able to comply with the follow-up schedule, including the second PSMA PET/CT scan. 6. Provide written informed consent. Exclusion Criteria 1. Any prior prostate cancer treatment (including hormonal therapy, radiotherapy, chemotherapy, or surgery) before baseline PSMA PET/CT. 2. 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). 3. Other active malignancy within the past two years, excluding non-melanoma skin cancer. 4. Severe comorbidities or conditions that, in the opinion of the investigator, could interfere with study compliance or pose a significant risk to the patient. 5. Unable or unwilling to provide informed consent.
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What it tests

  • Not listed
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Where

9 sites
The First Hospital of Lanzhou University
Lanzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
Qinghai University Affiliated Hospital
Xining, China
Weinan Central Hospital
Weinan, China
Shaanxi Provincial People's Hospital
Xi'an, China
Xijing 986 Hospital
Xi'an, China
Xijing Hospital
Xi'an, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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