Repeated PSMA PET scans to monitor treatment response in clinically significant prostate cancer.
Serial PSMA PET for Treatment Response Monitoring in Newly Diagnosed Clinically Significant, Treatment-Naïve Prostate Cancer - A Prospective, Multicenter Study
This project will test whether doing a PSMA PET/CT before treatment and again after treatment (or at early PSA rise) helps track response in people with newly diagnosed clinically significant (Gleason ≥7) prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Lanzhou, Gansu and 8 other locations) |
| Trial ID | NCT07553780 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with newly diagnosed, biopsy-proven prostate cancer with Gleason score ≥7 who have not received prior prostate cancer treatment and are able to undergo baseline and follow-up PSMA PET/CT.
Not a fit: Patients with low-risk disease (Gleason <7), those who already received prior prostate cancer treatment before baseline imaging, or those unable to undergo PSMA PET/CT are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could detect treatment failure earlier or confirm durable response, helping doctors tailor further therapy or surveillance.
How similar studies have performed: PSMA PET is already proven more sensitive than conventional imaging for detection and RECIP/PPP criteria have prognostic value in radioligand therapy, but prospective data on serial PSMA PET for routine therapy monitoring outside radiopharmaceutical contexts remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lanzhou, Gansu and 8 other locations
- 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)
Study contacts
- Study coordinator: Jianhua Jiao, MD.
- Email: 1531769428@qq.com
- Phone: +86 18700919857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.