Repeated PSMA PET scans to monitor treatment response in clinically significant prostate cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational cohort enrolling newly diagnosed clinically significant prostate cancer (Gleason score ≥7) patients planned for curative-intent or systemic therapy. Participants receive a baseline PSMA PET/CT before any prostate cancer treatment and a second PSMA PET/CT either at biochemical recurrence or at a fixed 12–24 month window after treatment completion for those without recurrence. The primary measure is absolute and relative change in lesion SUVmax between baseline and follow-up PET, correlated with response categories using a composite reference standard (PSA kinetics, conventional imaging, clinical outcomes). The study aims to clarify whether serial PSMA PET can reliably reflect treatment response across different therapies and to inform standardized response criteria in this setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Jianhua Jiao, MD.
• Email: 1531769428@qq.com
• Phone: +86 18700919857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.