PSICHE Trial Shows Promise for PSMA-PET–Guided Management of Biochemical Recurrence After Prostatectomy

In the PSICHE prospective, multicenter trial (NCT 05022914), researchers evaluated whether tailoring salvage therapy based on ^68Ga‑PSMA PET imaging might improve outcomes in men with biochemical recurrence (BCR) following radical prostatectomy.

Men with rising prostate-specific antigen (PSA between > 0.2 and ≤ 1.0 ng/mL) underwent PSMA‑PET staging. Based on imaging results, a predefined treatment algorithm assigned:

• Prostate bed–directed salvage radiotherapy (SRT) for negative scans or recurrence within the prostate bed,

• Stereotactic body radiotherapy (SBRT) for pelvic nodal recurrence or oligometastatic disease, and

• Androgen deprivation therapy (ADT) for widespread polymetastatic disease.

Among 159 enrolled patients, 107 had negative scans or local recurrence, 39 had pelvic nodal disease, 10 had oligometastatic extrapelvic lesions, and 3 had polymetastatic disease. Seventeen patients were observed (due to prior radiation or treatment refusal). Eighty‑eight patients received SRT, and 49 underwent SBRT. Stratifying by European Association of Urology (EAU) risk criteria (low risk = PSA doubling time > 12 months and Gleason < 8; high risk = doubling time ≤ 12 months or Gleason ≥ 8), the median follow-up was 19 months. There were no statistically significant differences in biochemical recurrence–free survival (BRFS) or metastasis-free survival (MFS) between risk groups (p = 0.58 for BRFS; p = 0.21 for MFS). Neither median metastasis-free survival nor median ADT-free survival had been reached at the time of analysis.

The authors conclude that a PSMA-targeted, imaging‑guided treatment strategy shows encouraging early results, potentially reducing overtreatment and toxicity from indiscriminate ADT or broad radiotherapy. They note that longer-term follow-up will be necessary to assess the durability of oncologic benefit.