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Utilization of molecular imaging in men with recurrent prostate cancer after definitive treatment is rapidly increasing. However, randomized data to guide preferred treatment approaches after molecular imaging are lacking, particularly for men with radiorecurrent, localized-only disease. We sought to evaluate patterns of care in these men, in order to understand the referral patterns and care plans implemented as a result of molecular imaging. From 2018-2020, 822 men were enrolled at a single institution on a prospective study (NCT03396874) assessing the diagnostic performance of 68Ga-PSMA-11 PET (PSMA) in men with biochemical recurrence after initial definitive therapy. Among the 196 (24%) treated with upfront definitive radiation therapy (RT), 58 had an isolated local recurrence and form the cohort for the present analysis. We evaluated the patterns of care including specialty of ordering provider, patterns of consulted specialties after PSMA, and subsequent management. Fifty-eight men had PSMA positive radiorecurrent localized-only disease (n=58/196, 30%). PSMA for these men was most ordered by medical oncology (38%), urology (36%), and radiation oncology (24%). Median PSA at time of PSMA was 4.6 ng/mL. Median interval between initial RT and PSMA was 9 years. After PSMA, 101 consultations were completed, 40 urology (40%), 33 radiation oncology (32%), and 28 medical oncology (28%). Twenty-one percent of men saw all three specialties (n=12), 38% two (n=22), and 41% one (n=24). Thirty-nine men (67%) underwent prostate MRI, and 35 (60%) had a prostate biopsy. In total, 26 men (45%) underwent local therapy, which included salvage RT in 14 men (54%) [brachytherapy (n=9), SBRT (n=5)], cryotherapy/HIFU in 11 men (42%), and salvage prostatectomy for one (4%). Among the 28 patients (48%) not undergoing local therapy, 32% (n=9) were poor local therapy candidates due to poor GU/GI quality of life or prior focal therapy and received systemic therapy alone. Approximately one-third of patients underwent observation (n=19), driven frequently by patient preference rather than local therapy eligibility or age-related comorbidities (n=12/19). Patient management and treatment varied by the specialty ordering the PSMA and subsequent referral patterns. Our data demonstrate significant heterogeneity in the management of patients with PSMA radiorecurrent localized-only prostate cancer. Treatment varied by ordering physician specialty and subsequent referral patterns after PSMA. As molecular imaging becomes more ubiquitous, our data demonstrate the need for multidisciplinary discussion as well as randomized trials in these patients to help guide the optimal treatment approach for this population. [ABSTRACT FROM AUTHOR]

Purpose/objective(s): Many men with locally advanced prostate cancer who undergo RP develop recurrence and require additional therapy. We hypothesized that neoadjuvant SBRT followed by RP may be a convenient, safe, and effective method to provide multi-modality therapy. Herein, we report the results of our phase I trial of neoadjuvant SBRT followed by RP in locally advanced prostate cancer.Materials/methods: Men with high-risk and clinical node positive prostate cancer were enrolled between 3/2017-10/2017 on a single center phase I trial (NCT02946008). The primary endpoint was 30-day post-RP complications based on operative blood loss, length of stay, readmission, drain or catheter replacement, with a composite goal of ≤28% of patients experiencing a dose-limiting toxicity (DLT), using a continual reassessment method. Dose level 0 and 1 delivered 30 Gy and 35 Gy in 5 fractions to the prostate/seminal vesicles, respectively. All patients received 25 Gy/5 fractions to the pelvic lymph nodes. RP was performed 4-10 weeks after SBRT. No hormone therapy was used. Acute and late toxicities were evaluated by CTCAE v.4.0. Quality of life (QoL) outcomes were obtained with the Expanded Prostate Cancer Index Composite (EPIC-26).Results: Median follow-up was 40 months (range, 33-44). Although the study was deemed safe by the 30-day primary endpoint (25% of patients experienced a DLT), the trial was stopped early after enrollment of 16 patients (38 originally planned) due to onset of late adverse events. RP was performed at a median of 6 weeks (range, 5-10). No grade 3 toxicities occurred during or post-SBRT/pre-RP. Post-RP, grade 3+ GU and GI toxicities occurred in 75% and 25% of patients, respectively. Two patients required cystectomy and urinary diversion ≥2 years post-RP. Mean EPIC QoL scores at baseline, post-SBRT/pre-RP, 3 months, 12 months and 24 months post-RP for urinary incontinence: 90 (82-99), 91 (84-97), 14 (5-22), 25 (7-42), and 42 (17-68); sexual function: 70 (54-85), 67 (50-83), 7 (2-12), 12 (5-20), 22 (10-34). No patients reported bothersome rectal bleeding. Seven patients (43%) had a biochemical recurrence, and five patients (31%) developed distant metastases. No patients developed a local or regional recurrence.Conclusion: Neoadjuvant SBRT to 30-35 Gy in 5 fractions followed by RP results in unacceptably high toxicity and severe QoL declines. Locoregional only treatment intensification is oncologically inadequate, as nearly half of men having recurred by 3 years post-treatment. Given the success of definitive radiotherapy plus hormone therapy in locally advanced prostate cancer, the combination of neoadjuvant SBRT and RP should not be further pursued. [ABSTRACT FROM AUTHOR]