scholarly journals Understanding and Improving 18F-Fluciclovine PET/CT Reports: A Guide for Physicians Treating Patients with Biochemical Recurrence of Prostate Cancer

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Benjamin H. Lowentritt ◽  
Michael S. Kipper
Keyword(s):  
Prostate Cancer ◽  
Amino Acid ◽  
Biochemical Recurrence ◽  
Specific Antigen ◽  
The Body ◽  
Bone Lesions ◽  
Detection Rates ◽  
Pet Ct ◽  
Management Plans ◽  
Referring Physicians

The positron emission tomography (PET) tracer 18F-fluciclovine has seen increasing use to localize disease in men with biochemical recurrence of prostate cancer, i.e., elevated prostate-specific antigen (PSA) levels post-treatment. 18F-Fluciclovine PET/computed tomography (CT) imaging reports now play central roles in many physician-patient discussions. However, because no standardized grading system or templates yet exist for 18F-fluciclovine image assessment, reports vary in format, comprehensiveness, and terminology and may be challenging to fully understand. To better utilize these documents, referring physicians should be aware of six key features of 18F-fluciclovine PET/CT. First, 18F-fluciclovine is a radiolabeled synthetic amino acid targeting the amino acid transporters ASCT2 and LAT1, which are ubiquitous throughout the body, but overexpressed in prostate cancer. Second, 18F-fluciclovine image interpretation is predominantly visual/qualitative: radiotracer uptake in suspicious lesions is compared with uptake in bone marrow or blood pool. Location of 18F-fluciclovine-avid lesions relative to typical recurrence sites and findings elsewhere in the patient are considered when evaluating lesions’ probability of malignancy, as is visibility on maximum intensity projection images when assessing bone lesions. Third, 18F-fluciclovine PET/CT detection rates increase as PSA levels rise. Fourth, detection rates may differ among centers, possibly due to equipment and reader experience. Fifth, since no diagnostic test is 100% accurate, scan data should not be used in isolation. Lastly, 18F-fluciclovine PET/CT findings frequently induce changes in disease management plans. In the prospective multicenter LOCATE and FALCON studies, scans altered management plans in 59% (126/213) and 64% (66/104) of patients, respectively; 78% (98/126) and 65% (43/66) of changes, respectively, involved modality switches. Referring physicians and imagers should collaborate to improve scan reports. Referrers should clearly convey critical information, including prescan PSA levels, and open clinical questions. Imagers should produce reports that read like consultations, avoid leaving open questions, and if needed, provide thoughts on next diagnostic steps.

scholarly journals O uso do PET/CT com PSMA 68GA no reestadiamento do câncer prostático em pacientes com recidiva bioquímica após prostatectomia radical / The use of PET / CT with PSMA 68GA in prostate cancer rehability in patients with received biochemical after radical prostatectomy

2021 ◽  
Vol 66 (1u) ◽  
pp. 1
Author(s):  
Gesislania De Sousa ◽  
Erik Lima ◽  
Felipe Favaro Capeleti ◽  
Rafael Eidi Goto ◽  
Homero José de Farias e Melo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Biochemical Recurrence ◽  
Specific Antigen ◽  
Treatment Change ◽  
Detection Rates ◽  
Therapeutic Decisions ◽  
Pubmed Database ◽  
Pet Ct ◽  
The Impact

Introdução: O Câncer de Próstata (CP) é o tumor maligno mais comum na população masculina acima dos 50 anos, sendo o adenocarcinoma o tipo histológico responsável por cerca de 95% dos casos. É o terceiro câncer com maior taxa de mortalidade entre os homens no mundo. A recorrência bioquímica do CP após prostatectomia radical é um problema clínico relevante. Objetivo: essa revisão teve como objetivo descrever o uso PET/CT-PSMA-68Ga no reestadiamento do CP nos casos de recidiva bioquímica após prostatectomia. Método: realizamos uma revisão bibliográfica na base de dados da PubMed, nos últimos três anos, de artigos publicados na íntegra. Resultados: Treze artigos foram usados na análise, a média da taxa de positividade do PET entre os estudos foi de 67.9%, variando de 34.4% a 89.5%. Discussão: todos os estudos concordam que maiores taxas de detecção foram diretamente proporcionais aos valores de PSA. Sete artigos mensuraram o impacto do PSMA na mudança terapêutica com uma média de 66.5% de alteração do tratamento (de 28.6% a 87.7%). Conclusão: Com base na análise dos artigos concluiu-se que o PET/CT-PSMA- - 68Ga na recorrência bioquímica do CP é útil na detecção de lesões locais e/ou metastáticas, e ainda importante no reestadiamento contribuindo nas decisões terapêuticas futuras.Palavras chave: Neoplasia prostática, Tomografia computadorizada, Recorrência, Bioquímica, PET/CT, Antígeno prostático específico Introduction: Prostate cancer (CP) is the most common malignant tumor in the male population over 50 years old, with adenocarcinoma being the histological type responsible for about 95% of cases. It is the third cancer with the highest mortality rate among men in the world. Biochemical recurrence of PC after radical prostatectomy is a relevant clinical problem. Objective: this review aimed to define the use of PET / CT-PSMA-68Ga without PC restaging in cases of biochemical recurrence after prostatectomy. Method: we performed a bibliographic review in the PubMed database, in the three years, of articles published in full. Results: Thirteen articles were used in the analysis, the average PET positivity rate between studies was 67.9%, varying from 34.4% to 89.5%. Discussion: all studies agree that higher detection rates were directly proportional to the PSA values. Seven articles measured the impact of PSMA on therapeutic change with an average of 66.5% of treatment change (from 28.6% to 87.7%). Conclusion: Based on the analysis of the concluded articles, PET / CT-PSMA-68Ga in the biochemical recurrence of PC is useful in the detection of sites and / or metastases, and also important in restaging, contributing to future therapeutic decisions. Keywords: Prostatic neoplasms, Computed tomography, Recurrence, Biochemistry, PET/CT, Prostate-specific antigen

Prospective head-to-head comparison of 18F-fluciclovine and 68Ga-PSMA-11 PET/CT for localization of prostate cancer biochemical recurrence after primary prostatectomy.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 15-15 ◽  
Author(s):  
Jeremie Calais ◽  
Francesco Ceci ◽  
Kathleen Nguyen ◽  
Jeannine Gartmann ◽  
Matthias Eiber ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Biochemical Recurrence ◽  
Detection Rate ◽  
Specific Antigen ◽  
Standard Of Care ◽  
Primary Study ◽  
Time Interval ◽  
Detection Rates ◽  
Pet Ct ◽  
Definitive Therapy

15 Background: 18F-Fluciclovine PET/CT (FACBC) is standard-of-care in US for localization of prostate cancer (PCa) biochemical recurrence (BCR) after definitive therapy. 68Ga-PSMA-11 PET/CT (PSMA) detects PCa BCR even at low prostate-specific antigen (PSA) levels (<2.0 ng/mL). We conducted a single-center prospective head-to-head comparison of these 2 PET/CT imaging tracers for localizing PCa BCR after radical prostatectomy (RP) in patients with PSA < 2.0 ng/ml. Methods: Patients with PCa BCR after RP and PSA levels ranging from ≥0.2 to ≤2.0 ng/mL without any prior salvage therapy were eligible. All patients underwent FACBC and PSMA scans within ≤15 days. Images analysis was performed a) by on-site clinical reading and b) by 3 blinded international expert readers for each modality. Detection rates on per-patient and per-region based analysis served as primary study endpoints. Based on literature data we hypothesized a detection rate difference of 22% in favor of PSMA. A power analysis determined a sample size of 50 patients. Results: The 50 patients were enrolled from March to September 2018. Median PSA level was 0.50 ng/ml. Median time interval between the 2 scans was 6 days. We present here the preliminary results from the non-blinded clinical reads. Detection rate on a per-patient basis was 69% for PSMA and 34% for FACBC. Concordant findings were observed in 30/49 patients (61%): 16/49 (32%) with both positive scans and 14/49 (29%) with both negative scans. Discordant findings were observed in 19/49 patients (39%): 18/49 (37%) had a positive PSMA but a negative FACBC scan while 1/49 (2%) had a positive FACBC with a negative PSMA (local recurrence). Detection rates were consistently lower for FACBC than for PSMA for all regions: Prostate bed (12% vs 20%), pelvic nodes (14% vs 37%), extra-pelvic nodes (2% vs 8%), skeleton (2% vs 8%) and visceral organs (2% vs 6%). Conclusions: This preliminary analysis from the non-blinded on-site clinical reads demonstrates prospectively that PSMA detection rates is more than double the FACBC detection rate in patients with PCa BCR after RP and with PSA ≤2.0 ng/ml. Clinical trial information: NCT03515577.

scholarly journals The Diagnostic Role of 18F-Choline, 18F-Fluciclovine and 18F-PSMA PET/CT in the Detection of Prostate Cancer With Biochemical Recurrence: A Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Rang Wang ◽  
Guohua Shen ◽  
Mingxing Huang ◽  
Rong Tian
Keyword(s):  
Prostate Cancer ◽  
Diagnostic Accuracy ◽  
Biochemical Recurrence ◽  
Meta Analysis ◽  
Detection Rates ◽  
Psma Pet ◽  
Pet Ct ◽  
Diagnostic Role ◽  
Sensitivity Specificity

BackgroundDiagnosing the biochemical recurrence (BCR) of prostate cancer (PCa) is a clinical challenge, and early detection of BCR can help patients receive optimal treatment. We conducted a meta-analysis to define the diagnostic accuracy of PET/CT using 18F-labeled choline, fluciclovine, and prostate-specific membrane antigen (PSMA) in patients with BCR.MethodsMultiple databases were searched until March 30, 2021. We included studies investigating the diagnostic accuracy of 18F-choline, 18F-fluciclovine, and 18F-PSMA PET/CT in patients with BCR. The pooled sensitivity, specificity, and detection rate of 18F-labeled tracers were calculated with a random-effects model.ResultsA total of 46 studies met the included criteria; 17, 16, and 13 studies focused on 18F-choline, fluciclovine, and PSMA, respectively. The pooled sensitivities of 18F-choline and 18F-fluciclovine were 0.93 (95% CI, 0.85–0.98) and 0.80 (95% CI, 0.65–0.897), and the specificities were 0.91 (95% CI, 0.73–0.97) and 0.66 (95% CI, 0.50–0.79), respectively. The pooled detection rates of 18F-labeled choline, fluciclovine and PSMA were 66, 74, and 83%, respectively. Moreover, the detection rates of 18F-labeled choline, fluciclovine, and PSMA were 35, 23, and 58% for a PSA level less than 0.5 ng/ml; 41, 46, and 75% for a PSA level of 0.5–0.99 ng/ml; 62, 57, and 86% for a PSA level of 1.0–1.99 ng/ml; 80, 92, and 94% for a PSA level more than 2.0 ng/ml.ConclusionThese three 18F-labeled tracers are promising for detecting BCR in prostate cancer patients, with 18F-choline showing superior diagnostic accuracy. In addition, the much higher detection rates of 18F-PSMA showed its superiority over other tracers, particularly in low PSA levels.Systematic Review RegistrationPROSPERO, identifier CRD42020212531.

scholarly journals Pattern of Prostate Cancer Recurrence Assessed by 68Ga-PSMA-11 PET/CT in Men Treated with Primary Local Therapy

2021 ◽  
Vol 10 (17) ◽  
pp. 3883
Author(s):  
Ismaheel O. Lawal ◽  
Thabo Lengana ◽  
Gbenga O. Popoola ◽  
Akintunde T. Orunmuyi ◽  
Mankgopo M. Kgatle ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Biochemical Recurrence ◽  
External Beam Radiotherapy ◽  
Prostate Gland ◽  
Local Treatment ◽  
Specific Antigen ◽  
Cancer Recurrence ◽  
Local Therapy ◽  
Lesion Detection ◽  
Pet Ct

Imaging plays a vital role in detecting the recurrence of prostate cancer (PCa) to guide the choice of salvage therapy. Gallium-68 prostate-specific membrane antigen positron-emission tomography/computed tomography (68Ga-PSMA-11 PET/CT) is useful for detecting PCa recurrence. We assessed the pattern of PCa recurrence stratified by serum prostate-specific antigen level and type of primary local treatment in men with biochemical recurrence (BCR) after primary local therapy with radical prostatectomy or external beam radiotherapy (EBRT) using 68Ga-PSMA-11 PET/CT. We reviewed patients imaged with 68Ga-PSMA-11 PET/CT for the localization of the site of PCa recurrence. We determined the site and number of lesions due to PCa recurrence at different PSA levels. A total of 247 men (mean age of 65.72 ± 7.51 years and median PSA of 2.70 ng/mL (IQR = 0.78–5.80)) were included. 68Ga-PSMA-11 PET/CT detected the site of recurrence in 81.4% of patients with a median number of lesions per patient of 1 (range = 1–5). 68Ga-PSMA-11 PET/CT positivity was 43.6%, 75.7%, 83.3%, 90.0%, and 95.8% at PSA levels of <0.5, 0.5–1.0., 1.1–2.0, 2.1–5.0, and 5.0–10.0, respectively. The most common site of recurrence was in the prostate gland/bed at all PSA levels. Pelvic, extra-pelvic, and combined pelvic and extra-pelvic sites of recurrence were seen in 118, 50, and 33 patients, respectively. The risk of extra-pelvic recurrence increases with rising PSA levels. 68Ga-PSMA-11 PET/CT has a high lesion detection rate for biochemical recurrence of PCa in patients previously treated with primary local therapy.

scholarly journals 18F-PSMA-1007 and 18F-fluorocholine PET/CT in prostate cancer progression diagnostics. First comparative experience

2019 ◽  
Vol 15 (3) ◽  
pp. 70-76
Author(s):  
N. A. Meshcheriakova ◽  
M. B. Dolgushin ◽  
A. I. Pronin ◽  
V. B. Matveev ◽  
A. A. Odzharova ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Progression ◽  
Specific Antigen ◽  
Bone Lesions ◽  
Prostate Cancer Progression ◽  
Radical Treatment ◽  
Positron Emission ◽  
Pet Ct ◽  
Computed Tomography Scans ◽  
Changes Detection

Background. Prostate cancer progression remains as a major problem among patients after their radical treatment. During last years a broad spectrum radiopharmaceuticals had developed to reveal the cause of biochemical recurrence.Objective: the comparison of 18F-fluorocholine and 18F-prostate-specific membrane antigen-1007 (18F-PSMA-1007) diagnostic abilities for the prostate cancer progression detection.Materials and methods. In this study had been included 18F-fluorocholine and 18F-PSMA-1007 PET/CT (positron emission tomography combined with computed tomography) scans of 9 patients after radical treatment with increased prostate-specific antigen (PSA) level (range 0.10–9.06 ng/ml).Results. 18F-PSMA-1007-PET/CT detected lesions in 7 (77.8 %) out of 9 patients, after radical prostatectomy and brachytherapy, in comparison with negative 18F-fluorocholine-PET/CT results in all cases.Conclusion. In this pilot study, 18F-PSMA-1007-PET/CT has showed high potential in pathological changes detection among patients with increased PSA level (minimum 0.10 ng/ml) and demonstrated the advantages in comparison with 18F-fluorocholine-PET/CT, especially in terms of revealing local recurrence and metastatic lymph nodes, as well as, in bone lesions early detection.

Multisite experience of fluciclovine (18F) PET/CT imaging in biochemically recurrent prostate cancer: Impact of clinical factors and intersite variation.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 163-163
Author(s):  
Lucia Zanoni ◽  
Christina Nanni ◽  
Tore Bach-Gansmo ◽  
Trond V Bogsrud ◽  
Peter Nieh ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Ct Scanning ◽  
Clinical Factors ◽  
Detection Rates ◽  
Prostate Bed ◽  
Pet Ct ◽  
Wide Range ◽  
The Impact ◽  
Baseline Psa

163 Background: Fluciclovine (18F) is an FDA-approved positron emission tomography/computerized tomography (PET/CT) tracer in clinical use for the detection and localization of biochemically recurrent (BCR) prostate cancer. Here, we report the impact of clinical factors and study site on its performance. Methods: In total, 596 subjects with BCR prostate cancer underwent fluciclovine (18F) PET/CT scanning at four sites in Italy, Norway and USA. Detection Rates (DR), including region level analyses, were stratified by prostate specific antigen (PSA) levels, PSA doubling time (PSAdt), Gleason score (GS), and by investigator/site. Extra-prostatic disease was defined as all positivity outside of residual prostate, prostate bed and seminal vesicles. Results: Fluciclovine (18F) PET/CT was positive in 67.7% (403/595) of subjects. Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232/599) and 32.6% (194/596) of scans, respectively. Metastatic involvement outside the pelvis was found in 26.2% (155/591) of scans. Generally, DR increased with increasing baseline PSA (Table 1). While subject level DR did not vary significantly with PSAdt (DR = 60-69% across all categories), a positive extra-prostatic scan was more likely in patients with shorter PSAdt (DR = 52%, 48%, 37% and 28% for PSAdt <3, 3-<6, 6-<12 and >12 months, respectively). Among 361 subjects for whom baseline GS was available, scores ≥9 were associated with the highest extra-prostatic DR (55%) compared with 23% in patients with GS ≤6. Inter-site variations in acquisition protocols may have impacted DR at low baseline PSA values; with subject level DR at PSA >0.2-0.5 ng/ml = 20%, 38%, 46% and 73% at site A, B, C and D, respectively. Conclusions: Fluciclovine (18F) can detect and localize BCR prostate cancer in a wide range of subjects and, with appropriate imaging protocols, has a clinically useful DR at PSA <0.5 ng/ml. Clinical trial information: NCT02443571. [Table: see text]

Identification of bone involvement in patients with prostate cancer recurrence using 18F-fluciclovine PET/CT and impact on subsequent management.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 248-248
Author(s):  
Michael S Kipper ◽  
Paul Dato ◽  
Keyword(s):  
Prostate Cancer ◽  
Prospective Trial ◽  
Specific Antigen ◽  
Cancer Recurrence ◽  
Bone Lesions ◽  
Curative Intent ◽  
Pet Tracer ◽  
Pet Ct ◽  
Prostate Cancer Recurrence ◽  
The Impact

248 Background: Bone is the most frequent site of metastasis in prostate cancer. Accurate localization of recurrence following primary treatment can help optimize salvage therapy. Positron emission tomography (PET) tracer, 18F-fluciclovine, is approved in Europe and the US for men with rising prostate specific antigen (PSA) after prior treatment. LOCATE was a prospective trial to study the impact of 18F-fluciclovine PET/computed tomography (PET/CT) on management of men with prostate cancer recurrence and negative standard imaging after curative intent treatment. Here, we explore changes in management (CIM) in men with 18F-fluciclovine-avid bone lesions. Methods: 18F-Fluciclovine PET/CT was performed and interpreted according to standard practice at 15 US centers. Eligible men (≥ 18 y; prior curative intent treatment of prostate cancer; recurrence based on rising PSA; negative/equivocal findings on standard bone and pelvic imaging) had their treatment plans recorded pre- and post-scan. Results: A total of 213 men (median pre-scan PSA, 1.0 ng/mL) were enrolled. Overall, 18F-fluciclovine detected lesions in 122 (57%) and 126 (59%) had CIM post-scan. 18F-Fluciclovine-avid bone lesions were found in 23 (11%) men. Prior to the fluciclovine scan, 21 (91%) had a 99mTc-MDP scan (20 negative, 1 equivocal results), 1 (4%) had an unspecified bone scan (negative result) and 1 (4%) did not receive a bone-specific scan. Of the 23 men with positive scans, 15 (65%) had post-scan CIM: ADT added to planned radiotherapy (RT; 4, 27%); ADT replaced with targeted treatment of fluciclovine-positive extrapelvic bony areas (4, 27%); RT modified to target fluciclovine-positive areas (4, 27%); modified ADT regime (2, 13%); and watchful waiting in favor of RT (1, 7%). The majority of men with no post-scan CIM were prescribed ADT (6/8, 75%). Conclusions: Despite negative standard bone imaging,18F-fluciclovine localized recurrence of prostate cancer to bone in 11% of patients; the majority of whom had a management change as a result, frequently in order to target fluciclovine-positive sites. Further study to investigate the clinical outcomes of such changes is warranted. Clinical trial information: NCT02680041.

Prospective evaluation of 18F-DCFPyL PET/CT in biochemically recurrent prostate cancer: Analysis of lesion localization and distribution.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5556-5556
Author(s):  
Hong Song ◽  
Heying Duan ◽  
Caitlyn Harrison ◽  
Kip Guja ◽  
Negin Hatami ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Biochemical Recurrence ◽  
Specific Antigen ◽  
Definitive Treatment ◽  
Low Grade ◽  
Prostate Bed ◽  
Academic Center ◽  
Pet Ct ◽  
One Stop ◽  
Post Radiation

5556 Background: 18F-DCFPyL, a promising PET agent targeting prostate specific membrane antigen (PSMA), is prospectively evaluated in a single academic center for detecting recurrent lesions in prostate cancer patients with biochemical recurrence (BCR). Methods: We prospectively enrolled 150 men (51-91 years old, mean ± SD: 70.3±7.5) with biochemical recurrence (PSA median 2.38 ng/mL, range 0.12 to 698.4) after primary definitive treatment with prostatectomy (65%), radiotherapy (35%) or both (19%). The 18F-DCFPyL positive lesions compatible with prostate cancer were evaluated by two independent readers. Impact of 18F-DCFPyL PET/CT on patient management was recorded from clinical chart review. Results: 18F-DCFPyL PET/CT had an overall positivity rate of 83% (125 scans), which increased with higher prostate specific antigen (PSA) levels (ng/mL): 63% (PSA < 0.5), 75% (0.5≤PSA < 1), 91% (1≤PSA < 2), 95% (2≤PSA < 5) and 98% (PSA≥5), respectively. In the cohort who underwent prostatectomy, 18F-DCFPyL PET/CT had higher positivity rate in patients with shorter PSA doubling time (PSAdt) (94% in PSAdt 0-3 months vs. 53% in PSAdt > 12 months, P< 0.01). No difference of 18F-DCFPyL positivity rate was observed in post-radiation patients with different PSAdt, nor were there differences between patients with low grade (Gleason 6) or higher-grade prostate cancer (Gleason 7-10). 20 patients (13%) had lesions in the prostate bed only and 41 patients (27%) had oligometastatic disease (1-3 lesions), making them candidates for locally targeted therapy. We identified a total of 1455 18F-DCFPyL positive lesions, including 51 lesions in the prostate bed, 271 pelvic and 463 extra-pelvic lymph nodes, approximately 585 osseous lesions, including 5 patients with diffuse osseous metastases, and 85 lesions in other organs (most commonly in the lungs). 91 out of 150 patients (61%) had change in treatment after 18F-DCFPyL PET and, most noticeably, 48 of these patients (32% total) had lesions only localized on 18F-DCFPyL PET/CT despite negative conventional imaging. Conclusions: 18F-DCFPyL PET/CT holds great potential to be a “one-stop shop” diagnostic tool in the work-up of BCR prostate cancer, with high (61%) impact on the management of these patients. Clinical trial information: NCT03501940 .

scholarly journals Restaging the Biochemical Recurrence of Prostate Cancer with [68Ga]Ga-PSMA-11 PET/CT: Diagnostic Performance and Impact on Patient Disease Management

Cancers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1594
Author(s):  
Aloÿse Fourquet ◽  
Lucien Lahmi ◽  
Timofei Rusu ◽  
Yazid Belkacemi ◽  
Gilles Créhange ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Disease Management ◽  
Biochemical Recurrence ◽  
High Performance ◽  
Detection Rate ◽  
Point Scale ◽  
Detection Rates ◽  
Pet Ct ◽  
The Impact

Background: Detection rates of [68Ga]Ga-PSMA-11 PET/CT on the restaging of prostate cancer (PCa) patients presenting with biochemical recurrence (BCR) have been well documented, but its performance and impact on patient management have not been evaluated as extensively. Methods: Retrospective analysis of PCa patients presenting with BCR and referred for [68Ga]Ga-PSMA-11 PET/CT. Pathological foci were classified according to six anatomical sites and evaluated with a three-point scale according to the uptake intensity. The impact of [68Ga]Ga-PSMA-11 PET/CT was defined as any change in management that was triggered by [68Ga]Ga-PSMA-11 PET/CT. The existence of a PCa lesion was established according to a composite standard of truth based on all clinical data available collected during the follow-up period. Results: We included 294 patients. The detection rate was 69%. Per-patient sensitivity and specificity were both 70%. Patient disease management was changed in 68% of patients, and [68Ga]Ga-PSMA-11 PET/CT impacted this change in 86% of patients. The treatment carried out on patient was considered effective in 89% of patients when guided by [68Ga]Ga-PSMA-11 PET/CT versus 61% of patients when not guided by [68Ga]Ga-PSMA-11 PET/CT (p < 0.001). Conclusions: [68Ga]Ga-PSMA-11 PET/CT demonstrated high performance in locating PCa recurrence sites and impacted therapeutic management in nearly two out of three patients.

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