A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve Prostate Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Not provided: No.

Study summary

Brief Summary： Under the support of the PROMISE scoring criteria, PSMA PET has demonstrated significant prognostic value. However, previous studies on PSMA PET included patients with various stages of prostate cancer, and the mixture of different disease stages may compromise the accuracy of prognostic tools. This study aims to specifically investigate the prognostic value of initial staging PSMA PET for progression-free survival in patients with newly diagnosed, treatment-naïve prostate cancer, and to develop corresponding prognostic tools.

Need:

The prognostic value of initial staging with PSMA PET is needed for treatment management and study design.

Primary Outcome:

To assess the prognostic value of initial staging by PSMA PET: generate a prognostic tool (PSMA-VISION score) based on initial staging of PSMA PET to predict progression-free survival.

Secondary Outcomes:

To compare PSMA-VISION score with the other prognostic tools (such as NCCN, STARCAP, PPP nomogram, PPP2 nomogram, etc.) and to evaluate the prognostic value of initial staging by PSMA PET to predict overall survival (OS). The correlation with clinicopathological variables and prediction of early progression (Exploratory) was also investigated.

Inclusion:

1. Patients with pathologically confirmed prostate cancer by prostate biopsy.
2. Undergone PSMA PET examination as initial staging before any treatment.
3. Have at least 2 years of follow-up data for progression-free survival and overall survival.

Exclusion Criteria:

1. Patients undergone any prior prostate cancer treatment before undergoing PSMA PET imaging.
2. Patients with metastasized or disseminated malignancy other than prostate cancer
3. Patients with neuroendocrine prostate cancer.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS) — Up to 2 years
  PFS is defined as the time from the date of baseline PSMA PET/CT to the date of first documented evidence of disease progression or death from any cause, whichever occurs first. Disease progression includes any of the following events: Biochemical recurrence (BCR): For patients without metastasis (M0) at baseline, defined per EAU/NCCN criteria as a PSA rise to ≥ 0.2 ng/mL (post-radical prostatectomy) and confirmed on a subsequent test, or a rise of ≥ 2 ng/mL above the nadir (post-radiotherapy). Locoregional progression: Imaging or pathologically confirmed local recurrence or regional lymph node metastasis. Distant metastasis: Imaging-confirmed new distant metastasis (M1a-c). Initiation of subsequent anticancer therapy: Start of a new line of treatment (e.g., ADT, chemotherapy, radiotherapy) due to disease progression.

Trial sites (9)

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