Prospective, Multisite, International Comparison of <sup>18</sup>F-Fluoromethylcholine PET/CT, Multiparametric MRI, and <sup>68</sup>Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes

Emmett, Louise; Metser, Ur; Bauman, Glenn; Hicks, Rodney J.; Weickhardt, Andrew; Davis, Ian D.; Punwani, Shonit; Pond, Gregory R.; Chua, Sue; Ho, Bao; Johnston, Edward; Pouliot, Frédéric; Scott, Andrew M.

doi:10.2967/jnumed.118.220103

Cited by 62 publications

(34 citation statements)

References 22 publications

(55 reference statements)

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“… 45 , 46 Improvements in prostate cancer imaging with multiparametric MRI (mpMRI) and PET may help identify isolated local recurrence and exclude metastatic disease, particularly with PSA levels ≥2 ng/mL. 47 , 48 , 49 , 50 Previously proposed selection criteria for local salvage include (1) biopsy proven recurrence, (2) no metastatic disease, (3) reasonable urinary function (International Prostate Symptom score of less than 20), (4) greater than 5-year life expectancy, (5) disease-free interval >2 years, (6) PSA doubling time greater than 6 months, (7) Gleason score ≤6, and (8) PSA of less than 10 at recurrence. 51 We propose modification to these criteria by carefully considering re-RT in those with Gleason scores greater than 6 (though caution should be used in those with initial high-risk disease).…”

Section: Discussionmentioning

confidence: 99%

A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis

Corkum

Mendez

Chin

et al. 2020

Advances in Radiation Oncology

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Purpose Reirradiation (re-RT) using external beam radiation therapy (EBRT) is a novel salvage strategy for local failure in prostate cancer. We performed a systematic review describing oncologic and toxicity outcomes for salvage EBRT/stereotactic radiation therapy (SBRT) re-RT. Methods and Materials A International Prospective Register of Systematic Reviews registered (#141466) systematic review, meta-analysis, and meta-regression was conducted using preferred reporting items for systematic reviews and meta-analyses guidelines. PubMed and EMBASE were searched from inception through September 2019. Outcome measures included local control (LC), biochemical relapse free survival (BRFS), and ≥grade 3 genitourinary (GU)/gastrointestinal (GI) toxicity. EBRT and SBRT data were collected separately. Meta-regression explored disease and toxicity outcomes as a function of equivalent dose in 2 Gy fractions (EQD2), length of follow-up, and partial versus whole prostate reirradiation. Results Nineteen studies representing 13 cohorts were included (428 patients). Weighted mean follow-up was 26.1 months. Median re-RT EQD2 was 77.1 Gy (α/β = 1.5), with 92% of patients receiving SBRT, 52.1% of patients receiving partial prostate re-RT, and 30.1% of patients receiving androgen deprivation therapy with re-RT. LC was 83.2% (95% confidence interval [CI], 75.5%-90.9%) and BRFS was 59.3% (47.9%-70.7%). Reported late toxicity ≥grade 3 was 3.4% (95% CI, 1.0%-5.8%) for GU and 2.0% (95% CI, 0.1%-4.0%) for GI. Meta-regression found higher LC, BRFS, and reported GU/GI toxicity with increasing EQD2, with partial prostate re-RT associated with less reported GU/GI toxicity and no detriment to LC and BRFS. Conclusions Salvage re-RT using EBRT, particularly with SBRT, is an emerging technique to treat isolated local failure of prostate cancer. With short-term follow-up, LC, BRFS, and reported toxicities appear reasonable, although further follow-up is required before definitive statements on late toxicities can be made. Our review is limited by incomplete reporting of androgen deprivation therapy use in the primary literature. Further prospective studies and longer follow-up are needed before considering re-RT as standard practice.

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Section: Discussionmentioning

confidence: 99%

A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis

Corkum

Mendez

Chin

et al. 2020

Advances in Radiation Oncology

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“…The nuclear medicine team in Heidelberg reported in 2014 that PET/CT with PSMA-11 (also known as PSMA-HBED-CC), a 68 Ga-labelled ligand of the prostate-specific membrane antigen (PSMA), can evidence prostate cancer (PC) tissue undetected with 18 F-fluorocholine (FCH) [1]. The excellent diagnostic performance of PSMA-11 as the first-line PET/ CT to detect biochemical recurrence (BCR) of PC has now been assessed in large series by different teams [2][3][4][5][6][7][8][9]; a few head-to-head comparative studies also confirmed its superior diagnostic performance over FCH [1,10,11]. But PSMA-11 is labelled with gallium-68, the 68-min half-life of which actually imposes to practice on-site labelling that requires trained personnel, 68 Ge/ 68 Ga generator, and dedicated devices.…”

Section: Introductionmentioning

confidence: 99%

“…Since PSMA- 11 is not yet registered for clinical use in France, the National Agency for Medicine Security (ANSM) granted nominative authorisations (ATUs) on a per-patient basis. As FCH had been registered for imaging PC since 2010 in France, ATUs can only be delivered for patients whose previous FCH PET/CT yielded a negative or equivocal result.…”

Section: Introductionmentioning

confidence: 99%

Survey by the French Medicine Agency (ANSM) of the imaging protocol, detection rate, and safety of 68Ga-PSMA-11 PET/CT in the biochemical recurrence of prostate cancer in case of negative or equivocal 18F-fluorocholine PET/CT: 1084 examinations

Chevalme

Boudali

Gauthé

et al. 2021

Eur J Nucl Med Mol Imaging

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Introduction Despite growing evidence of a superior diagnostic performance of 68Ga-PSMA-11 over 18F-fluorocholine (FCH) PET/CT, the number of PET/CT centres able to label on site with gallium-68 is still currently limited. Therefore, patients with biochemical recurrence (BCR) of prostate cancer frequently undergo FCH as the 1st-line PET/CT. Actually, the positivity rate (PR) of a second-line PSMA-11 PET/CT in case of negative FCH PET/CT has only been reported in few short series, in a total of 185 patients. Our aims were to check (1) whether the excellent PR reported with PSMA-11 is also obtained in BCR patients whose recent FCH PET/CT was negative or equivocal; (2) in which biochemical and clinical context a high PSMA-11 PET/CT PR may be expected in those patients, in particular revealing an oligometastatic pattern; (3) whether among the various imaging protocols for PSMA-11 PET/CT used in France, one yields a significantly highest PR; (4) the tolerance of PSMA-11. Patients and methods Six centres performed 68Ga-PSMA-11 PET/CTs during the first 3 years of its use in France. Prior to each PET/CT, the patient’s data were submitted prospectively for authorisation to ANSM, the French Medicine Agency. The on-site readings of 1084 PSMA-11 PET/CTs in BCR patients whose recent FCH PET/CTs resulted negative or equivocal were pooled and analysed. Results (1) The overall PR was 68%; for a median serum PSA level (sPSA) of 1.7 ng/mL, an oligometastatic pattern (1–3 foci) was observed in 31% of the cases overall; (2) PR was significantly related to sPSA (from 41% if < 0.2 ng/mL to 81% if ≥ 2 ng/mL), to patients’ age, to initial therapy (64% if prostatectomy vs. 85% without prostatectomy due to frequent foci in the prostate fossa), to whether FCH PET/CT was negative or equivocal (PR = 62% vs. 82%), and to previous BCR (PR = 63% for 1st BCR vs. 72% in case of previous BCR); (3) no significant difference in PR was found according to the imaging protocol: injected activity, administration of a contrast agent and/or of furosemide, dose length product, one single or multiple time points of image acquisition; (4) no adverse event was reported after PSMA-11 injection, even associated with a contrast agent and/or furosemide. Conclusion Compared with the performance of PSMA-11 PET/CT in BCR reported independently of FCH PET/CT in 6 large published series (n > 200), the selection based on FCH PET/CT resulted in no difference of PSMA-11 PR for sPSA < 1 ng/mL but in a slightly lower PR for sPSA ≥ 1 ng/mL, probably because FCH performs rather well at this sPSA and very occult BCR was over-represented in our cohort. An oligometastatic pattern paving the way to targeted therapy was observed in one fourth to one third of the cases, according to the clinico-biochemical context of the BCR. Systematic dual or triple acquisition time points or administration of a contrast agent and/or furosemide did not bring a significant added value for PSMA-11 PET/CT positivity and should be decided on individual bases.

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“…Consequently, the results of our study contribute to the growing body of evidence for high prevalence of PET-M1 disease in patients nonmetastatic by conventional imaging. Degree of upstaging by PSMA-PET/CT depends on extent of conventional imaging, however prior head-to-head comparison indicates low impact of additional MRI and/or bone scan on early detection of metastases (11)(12)(13). In the light of recent clinical trials showing improved outcome in nmCRPC patients, such as SPARTAN (14) or ARAMIS (15), we assume that about half of subjects enrolled in these trials did indeed have metastatic disease detectable by PET.…”

Section: Discussionmentioning

confidence: 99%

PSMA-Ligand PET for Early Castration-Resistant Prostate Cancer: A Retrospective Single-Center Study

et al. 2020

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Prospective, Multisite, International Comparison of ¹⁸F-Fluoromethylcholine PET/CT, Multiparametric MRI, and ⁶⁸Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes

Cited by 62 publications

References 22 publications

A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis

A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis

Survey by the French Medicine Agency (ANSM) of the imaging protocol, detection rate, and safety of 68Ga-PSMA-11 PET/CT in the biochemical recurrence of prostate cancer in case of negative or equivocal 18F-fluorocholine PET/CT: 1084 examinations

PSMA-Ligand PET for Early Castration-Resistant Prostate Cancer: A Retrospective Single-Center Study

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Prospective, Multisite, International Comparison of 18F-Fluoromethylcholine PET/CT, Multiparametric MRI, and 68Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes

Cited by 62 publications

References 22 publications

A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis

A Novel Salvage Option for Local Failure in Prostate Cancer, Reirradiation Using External Beam or Stereotactic Radiation Therapy: Systematic Review and Meta-Analysis

Survey by the French Medicine Agency (ANSM) of the imaging protocol, detection rate, and safety of 68Ga-PSMA-11 PET/CT in the biochemical recurrence of prostate cancer in case of negative or equivocal 18F-fluorocholine PET/CT: 1084 examinations

PSMA-Ligand PET for Early Castration-Resistant Prostate Cancer: A Retrospective Single-Center Study

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Prospective, Multisite, International Comparison of ¹⁸F-Fluoromethylcholine PET/CT, Multiparametric MRI, and ⁶⁸Ga-HBED-CC PSMA-11 PET/CT in Men with High-Risk Features and Biochemical Failure After Radical Prostatectomy: Clinical Performance and Patient Outcomes