Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", University of Florence, Florence, Italy.
Prostate. 2023 Sep;83(12):1201-1206. doi: 10.1002/pros.24579. Epub 2023 Jun 8.
Ultrasensitive imaging has been demonstrated to influence biochemical relapse treatment. PSICHE is a multicentric prospective study, aimed at exploring detection rate with 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) and outcomes with a predefined treatment algorithm tailored to the imaging.
Patients affected by biochemical recurrence after surgery (prostate specific antigen [PSA] > 0.2 < 1 ng/mL) underwent staging with 68Ga-PSMA PET/CT. Management followed this treatment algorithm accordingly with PSMA results: prostate bed salvage radiotherapy (SRT) if negative or positive within prostate bed, stereotactic body radiotherapy (SBRT) if pelvic nodal recurrences or oligometastatic disease, androgen deprivation therapy (ADT) if nonoligometastatic disease. Chi-square test was used to evaluate the relationship between baseline features and rate of positive PSMA PET/CT.
One hundred patients were enrolled. PSMA results were negative/positive in the prostate bed in 72 patients, pelvic nodal or extrapelvic metastatic disease were detected in 23 and 5 patients. Twenty-one patients underwent observation because of prior postoperative radiotherapy (RT)/treatment refusal. Fifty patients were treated with prostate bed SRT, 23 patients underwent SBRT to pelvic nodal disease, five patients were treated with SBRT to oligometastatic disease. One patient underwent ADT. NCCN high-risk features, stage > pT3 and ISUP score >3 reported a significantly higher rate of positive PSMA PET/CT after restaging (p = 0.01, p = 0.02, and p = 0.002). By quartiles of PSA, rate of positive PSMA PET/CT was 26.9% (>0.2; <0.29 ng/mL), 24% (>0.3; <0.37 ng/mL), 26.9% (>0.38; <0.51 ng/mL), and 34.7% (>0. 52; <0.98 ng/mL).
PSICHE trial constitute a useful platform to collect data within a clinical framework where modern imaging and metastasis-directed therapy are integrated.
超敏成像已被证明会影响生化复发的治疗。PSICHE 是一项多中心前瞻性研究，旨在探索 68Ga-PSMA-11 正电子发射断层扫描/计算机断层扫描（PET/CT）的检出率，并根据成像结果探索预设治疗方案的治疗效果。
接受过手术后生化复发（前列腺特异性抗原 [PSA] > 0.2 < 1ng/mL）的患者进行 68Ga-PSMA PET/CT 分期。根据 PSMA 结果，管理遵循该治疗方案：如果前列腺床内为阴性或阳性，则进行前列腺床挽救性放疗（SRT）；如果存在盆腔淋巴结复发或寡转移疾病，则进行立体定向体部放疗（SBRT）；如果存在非寡转移疾病，则进行雄激素剥夺治疗（ADT）。卡方检验用于评估基线特征与 PSMA PET/CT 阳性率之间的关系。
共纳入 100 例患者。72 例患者的 PSMA 结果在前列腺床内为阴性/阳性，23 例和 5 例患者检测到盆腔淋巴结或盆腔外转移疾病。由于术后放疗（RT）/治疗拒绝，21 例患者接受观察。50 例患者接受前列腺床 SRT 治疗，23 例患者接受盆腔淋巴结疾病 SBRT 治疗，5 例患者接受寡转移疾病 SBRT 治疗。1 例患者接受 ADT 治疗。NCCN 高危特征、分期>pT3 和 ISUP 评分>3 的患者，在重新分期后 PSMA PET/CT 阳性率显著更高（p=0.01、p=0.02 和 p=0.002）。根据 PSA 的四分位数，PSMA PET/CT 阳性率分别为 26.9%（>0.2；<0.29ng/mL）、24%（>0.3；<0.37ng/mL）、26.9%（>0.38；<0.51ng/mL）和 34.7%（>0.52；<0.98ng/mL）。
PSICHE 试验构成了一个有用的平台，可以在一个将现代成像和转移性治疗相结合的临床框架内收集数据。
