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Staging of Biochemically Relapsing Prostate Cancer Using the Positron Emission Tomography Tracer Fluciclovine F18
S112
International Journal of Radiation Oncology Biology Physics
251
Rochester, MN, 2Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 3Department of Radiology, Mayo Clinic, Rochester, MN
Staging of Biochemically Relapsing Prostate Cancer Using the Positron Emission Tomography Tracer Fluciclovine F18 T. Bach-Gansmo,1 C. Nanni,2 P. Nieh,3 L. Zanoni,2 T. Bogsrud,1 H. Sletten,1 K. Korsan,1 J. Kieboom,4 A. Chau,5 P. Ward,5 F. Willoch,6 M. Goodman,3 S. Fanti,2 and D.M. Schuster3; 1Oslo University Hospital, Oslo, Norway, 2Ospedale St’Orsola, Bologna, Italy, 3Emory University, Atlanta, GA, 4Aleris Healthcare, Oslo, Norway, 5Blue Earth Diagnostics, Oxford, United Kingdom, 6University of Oslo, Oslo, Norway Purpose/Objective(s): Staging the extent and location of prostate cancer in biochemical relapse (BR) is critical to informing further management of both post-surgical and post-radiation patients with focal or systemic therapies. This retrospective, observational study hypothesized that the investigational amino acid PET tracer fluciclovine F18 could effectively detect disease recurrence in this patient group and would be well tolerated. Diagnostic performance of fluciclovine F18, as compared to histopathology and clinical follow-up, was determined in a patient cohort with sufficient data for truth determination. The safety profile and imaging positivity rate relative to PSA level were evaluated in the larger cohort. Materials/Methods: Overall, 714 cancer patients underwent fluciclovine F18 PET-CT scanning at 4 sites in Norway, Italy and USA, including 596 patients who presented with BR of prostate cancer. Imaging positivity or detection rate (DR) was determined according to PSA quartile. To determine diagnostic performance in prostate cancer BR, fluciclovine F18 PET-CT results were compared to available histopathological findings (n Z 143) and to histopathology plus clinical follow-up (n Z 125). Determination of DR, sensitivity and specificity, positive and negative predictive value (PPV, NPV) were made, as applicable, at lesion, regional and subject level (prostate/prostate bed (P/B) or extraprostatic (E/P)). Results: Fluciclovine F18 was very well tolerated: adverse events possibly related to fluciclovine were reported by 0.6% of patients; no significant treatment-related effects on laboratory values or ECG variables were noted. Risk factors for the prostate cancer BR cohort included: Gleason score 7 (80%); intermediate/high risk by D’Amico criteria at initial treatment (65%); median PSA before imaging: 2.03 ng/mL. For diagnostic performance vs. histopathology (n Z 143) the sensitivity for detection of P/B disease was 88.1%, with specificity of 32.6% and PPV of 71.8%. The PPV for E/P disease was higher at 92.3%. For diagnostic performance vs pathology plus clinical follow up (n Z 125), sensitivity, specificity, PPV, and NPV for the regions P/B and E/P were: P/B: 95.1%, 48.8%, 78%, and 84%, and E/P: 84.2%, 89.7%, 78.0%, and 92.9%. Analysis of patient level DR (%) by PSA quartile (ng/mL) in the full BR cohort (n Z 596) was: 0.79: 41%; >0.79 to 2.03: 59%; >2.03 to 6.0: 75%; >6.0: 86%. Conclusion: Fluciclovine (18F) PET-CT scanning is well tolerated and able to sensitively detect recurrent prostate cancer, even at PSA levels below 1ng/mL, potentially facilitating the optimization of subsequent patient management, including the scope and dose of radiotherapy. Author Disclosure: T. Bach-Gansmo: None. C. Nanni: None. P. Nieh: None. L. Zanoni: None. T. Bogsrud: None. H. Sletten: None. K. Korsan: None. J. Kieboom: None. A. Chau: Consultant; Blue Earth Diagnostics. P. Ward: Consultant; Blue Earth Diagnostics. F. Willoch: None. M. Goodman: None. S. Fanti: None. D.M. Schuster: Research Grant; Blue Earth Diagnostics. Consultant; Blue Earth Diagnostics.
252 Patterns of Recurrence Following Primary Radiation Therapy for Prostate Cancer Using C-11 Choline Positron Emission Tomography/ Computed Tomography: Unique Identification of Sites of Recurrence Impacting Clinical Management W.P. Parker,1 B.J. Davis,2 S.S. Park,2 K. Olivier,2 C.R. Choo,2 M.A. Nathan,3 V.J. Lowe,3 T.J. Welch,3 H.B. Zaid,1 I.I. Sobol,1 M.K. Tollefson,1 M.T. Gettman,1 S.A. Boorjian,1 L.A. Mynderse,1 J.R. Karnes,1 and E.D. Kwon1; 1Department of Urology, Mayo Clinic,
Purpose/Objective(s): To describe patterns of recurrence and associated clinical factors following primary external beam radiation therapy (RT) and/or brachytherapy (BT) for prostate cancer (CaP) patients (pts) as identified on C-11 choline PET/CT scan (CholPET). Materials/Methods: Between 2007 and 2015, a total of 204 pts with a rising serum prostate specific antigen (PSA) post-therapy and PSA < 20 ng/mL were imaged with CholPET and other conventional imaging modalities. Imaging findings and clinical characteristics were analyzed using uni- and multivariable logistic regression. Results: A total of 181 (88.7%) pts were identified with recurrence on CholPET; results presented in Table 1. Factors associated with a positive CholPET were NCCN risk group (intermediate risk [OR Z 1.35; P Z 0.55], high risk [OR Z 11.49; P Z 0.02]), and PSA at CholPET (OR Z 1.26 per 1 ng/mL increase; P < 0.01). A total of 112 (62%) pts had recurrence localized to the pelvic soft tissue only with median PSA of 5.2 (IQR: 3.6-8.2), compared to 69 (38%) pts who had evidence of extrapelvic and/or osseous disease with median PSA of 7.3 (IQR: 4.5-12.0) (P < 0.003). A total of 112 (69%) pts had an MRI performed, and CholPET uniquely identified 18 / 112 (16%) pts with pelvic only recurrences and 13 / 69 (19%) pts with extrapelvic spread. Biopsy confirmation was performed in 69 / 112 (76.7%) pts with pelvic only recurrence and 21 / 69 (23.3%) pts with extrapelvic recurrence; the remainder was confirmed by treatment response. PSA velocity was most strongly associated with recurrence pattern, where a cut-point of 2.4 ng/mL/year was associated with the greatest discrimination between local soft tissue (OR 3.33 for PSA velocity <2.4 ng/mL/year; P < 0.001) vs. extrapelvic recurrence (OR 3.91 for PSA velocity 2.4 ng/mL/year; P < 0.001). Among pts who underwent CholPET prior to BCR per the Phoenix definition (n Z 25), 19 (76.0%) had a positive scan with 13 (68.4%) having recurrence localized to the pelvis and the remainder with extrapelvic recurrence. Conclusion: C-11 choline PET/CT improves the localization of site of recurrence in pts with rising PSA post primary RT, allowing appropriate selection of systemic and/or local salvage therapies. Supported in part by NCI Grant R01 CA200551. Abstract 252; Table 1 Pelvic Soft Tissue Total Risk Group at RT Low Risk Intermediate Risk High/Very High Risk PSA at PET Scan (ng/mL) PSA Doubling Time (months) PSA Velocity (ng/mL/year) Time to PET from RT completion (months)
112 30 49 23 5.2 13 1.2 78
Extrapelvic/ Osseous
P value
69 (29.4) (48.0) (22.5) (3.6 e 8.2) (8 e 26) (0.6 e 2.1) (48 e 120)
11 27 27 7.3 6 2.5 50
(16.9) (41.5) (41.5) (4.5 e 12.0) (4.4 e 14.0) (0.9 e 5.7) (28 e 90)
0.02 <0.01 <0.01 <0.01 <0.01
Author Disclosure: W.P. Parker: None. B.J. Davis: None. S.S. Park: None. K. Olivier: None. C. Choo: None. M.A. Nathan: None. V.J. Lowe: Advisory Board; Bayer Schering Pharma, Piramal Life Sciences. Research Funding; GE Healthcare, Siemens, AVID Radiopharmaceuticals. T.J. Welch: None. H.B. Zaid: None. I.I. Sobol: None. M.K. Tollefson: None. M.T. Gettman: None. S.A. Boorjian: None. L.A. Mynderse: Research agreement use of biopsy equipment; Phillips Healthcare. J.R. Karnes: None. E.D. Kwon: None.
253 The Role of Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography in the Management of Patients With Prostate Cancer: Implications for Selection of Patients for Radiation Therapy U. Amit,1 J.D. Goldstein,1 T. Davidson,2 M. Hahiashvili,2 E. Goshen,2 Y. Oksman,2 R. Berger,3 A. Saad,1 I. Sadetsky,1 B. Chikman,4
International Journal of Radiation Oncology Biology Physics
251
Rochester, MN, 2Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 3Department of Radiology, Mayo Clinic, Rochester, MN
Staging of Biochemically Relapsing Prostate Cancer Using the Positron Emission Tomography Tracer Fluciclovine F18 T. Bach-Gansmo,1 C. Nanni,2 P. Nieh,3 L. Zanoni,2 T. Bogsrud,1 H. Sletten,1 K. Korsan,1 J. Kieboom,4 A. Chau,5 P. Ward,5 F. Willoch,6 M. Goodman,3 S. Fanti,2 and D.M. Schuster3; 1Oslo University Hospital, Oslo, Norway, 2Ospedale St’Orsola, Bologna, Italy, 3Emory University, Atlanta, GA, 4Aleris Healthcare, Oslo, Norway, 5Blue Earth Diagnostics, Oxford, United Kingdom, 6University of Oslo, Oslo, Norway Purpose/Objective(s): Staging the extent and location of prostate cancer in biochemical relapse (BR) is critical to informing further management of both post-surgical and post-radiation patients with focal or systemic therapies. This retrospective, observational study hypothesized that the investigational amino acid PET tracer fluciclovine F18 could effectively detect disease recurrence in this patient group and would be well tolerated. Diagnostic performance of fluciclovine F18, as compared to histopathology and clinical follow-up, was determined in a patient cohort with sufficient data for truth determination. The safety profile and imaging positivity rate relative to PSA level were evaluated in the larger cohort. Materials/Methods: Overall, 714 cancer patients underwent fluciclovine F18 PET-CT scanning at 4 sites in Norway, Italy and USA, including 596 patients who presented with BR of prostate cancer. Imaging positivity or detection rate (DR) was determined according to PSA quartile. To determine diagnostic performance in prostate cancer BR, fluciclovine F18 PET-CT results were compared to available histopathological findings (n Z 143) and to histopathology plus clinical follow-up (n Z 125). Determination of DR, sensitivity and specificity, positive and negative predictive value (PPV, NPV) were made, as applicable, at lesion, regional and subject level (prostate/prostate bed (P/B) or extraprostatic (E/P)). Results: Fluciclovine F18 was very well tolerated: adverse events possibly related to fluciclovine were reported by 0.6% of patients; no significant treatment-related effects on laboratory values or ECG variables were noted. Risk factors for the prostate cancer BR cohort included: Gleason score 7 (80%); intermediate/high risk by D’Amico criteria at initial treatment (65%); median PSA before imaging: 2.03 ng/mL. For diagnostic performance vs. histopathology (n Z 143) the sensitivity for detection of P/B disease was 88.1%, with specificity of 32.6% and PPV of 71.8%. The PPV for E/P disease was higher at 92.3%. For diagnostic performance vs pathology plus clinical follow up (n Z 125), sensitivity, specificity, PPV, and NPV for the regions P/B and E/P were: P/B: 95.1%, 48.8%, 78%, and 84%, and E/P: 84.2%, 89.7%, 78.0%, and 92.9%. Analysis of patient level DR (%) by PSA quartile (ng/mL) in the full BR cohort (n Z 596) was: 0.79: 41%; >0.79 to 2.03: 59%; >2.03 to 6.0: 75%; >6.0: 86%. Conclusion: Fluciclovine (18F) PET-CT scanning is well tolerated and able to sensitively detect recurrent prostate cancer, even at PSA levels below 1ng/mL, potentially facilitating the optimization of subsequent patient management, including the scope and dose of radiotherapy. Author Disclosure: T. Bach-Gansmo: None. C. Nanni: None. P. Nieh: None. L. Zanoni: None. T. Bogsrud: None. H. Sletten: None. K. Korsan: None. J. Kieboom: None. A. Chau: Consultant; Blue Earth Diagnostics. P. Ward: Consultant; Blue Earth Diagnostics. F. Willoch: None. M. Goodman: None. S. Fanti: None. D.M. Schuster: Research Grant; Blue Earth Diagnostics. Consultant; Blue Earth Diagnostics.
252 Patterns of Recurrence Following Primary Radiation Therapy for Prostate Cancer Using C-11 Choline Positron Emission Tomography/ Computed Tomography: Unique Identification of Sites of Recurrence Impacting Clinical Management W.P. Parker,1 B.J. Davis,2 S.S. Park,2 K. Olivier,2 C.R. Choo,2 M.A. Nathan,3 V.J. Lowe,3 T.J. Welch,3 H.B. Zaid,1 I.I. Sobol,1 M.K. Tollefson,1 M.T. Gettman,1 S.A. Boorjian,1 L.A. Mynderse,1 J.R. Karnes,1 and E.D. Kwon1; 1Department of Urology, Mayo Clinic,
Purpose/Objective(s): To describe patterns of recurrence and associated clinical factors following primary external beam radiation therapy (RT) and/or brachytherapy (BT) for prostate cancer (CaP) patients (pts) as identified on C-11 choline PET/CT scan (CholPET). Materials/Methods: Between 2007 and 2015, a total of 204 pts with a rising serum prostate specific antigen (PSA) post-therapy and PSA < 20 ng/mL were imaged with CholPET and other conventional imaging modalities. Imaging findings and clinical characteristics were analyzed using uni- and multivariable logistic regression. Results: A total of 181 (88.7%) pts were identified with recurrence on CholPET; results presented in Table 1. Factors associated with a positive CholPET were NCCN risk group (intermediate risk [OR Z 1.35; P Z 0.55], high risk [OR Z 11.49; P Z 0.02]), and PSA at CholPET (OR Z 1.26 per 1 ng/mL increase; P < 0.01). A total of 112 (62%) pts had recurrence localized to the pelvic soft tissue only with median PSA of 5.2 (IQR: 3.6-8.2), compared to 69 (38%) pts who had evidence of extrapelvic and/or osseous disease with median PSA of 7.3 (IQR: 4.5-12.0) (P < 0.003). A total of 112 (69%) pts had an MRI performed, and CholPET uniquely identified 18 / 112 (16%) pts with pelvic only recurrences and 13 / 69 (19%) pts with extrapelvic spread. Biopsy confirmation was performed in 69 / 112 (76.7%) pts with pelvic only recurrence and 21 / 69 (23.3%) pts with extrapelvic recurrence; the remainder was confirmed by treatment response. PSA velocity was most strongly associated with recurrence pattern, where a cut-point of 2.4 ng/mL/year was associated with the greatest discrimination between local soft tissue (OR 3.33 for PSA velocity <2.4 ng/mL/year; P < 0.001) vs. extrapelvic recurrence (OR 3.91 for PSA velocity 2.4 ng/mL/year; P < 0.001). Among pts who underwent CholPET prior to BCR per the Phoenix definition (n Z 25), 19 (76.0%) had a positive scan with 13 (68.4%) having recurrence localized to the pelvis and the remainder with extrapelvic recurrence. Conclusion: C-11 choline PET/CT improves the localization of site of recurrence in pts with rising PSA post primary RT, allowing appropriate selection of systemic and/or local salvage therapies. Supported in part by NCI Grant R01 CA200551. Abstract 252; Table 1 Pelvic Soft Tissue Total Risk Group at RT Low Risk Intermediate Risk High/Very High Risk PSA at PET Scan (ng/mL) PSA Doubling Time (months) PSA Velocity (ng/mL/year) Time to PET from RT completion (months)
112 30 49 23 5.2 13 1.2 78
Extrapelvic/ Osseous
P value
69 (29.4) (48.0) (22.5) (3.6 e 8.2) (8 e 26) (0.6 e 2.1) (48 e 120)
11 27 27 7.3 6 2.5 50
(16.9) (41.5) (41.5) (4.5 e 12.0) (4.4 e 14.0) (0.9 e 5.7) (28 e 90)
0.02 <0.01 <0.01 <0.01 <0.01
Author Disclosure: W.P. Parker: None. B.J. Davis: None. S.S. Park: None. K. Olivier: None. C. Choo: None. M.A. Nathan: None. V.J. Lowe: Advisory Board; Bayer Schering Pharma, Piramal Life Sciences. Research Funding; GE Healthcare, Siemens, AVID Radiopharmaceuticals. T.J. Welch: None. H.B. Zaid: None. I.I. Sobol: None. M.K. Tollefson: None. M.T. Gettman: None. S.A. Boorjian: None. L.A. Mynderse: Research agreement use of biopsy equipment; Phillips Healthcare. J.R. Karnes: None. E.D. Kwon: None.
253 The Role of Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography in the Management of Patients With Prostate Cancer: Implications for Selection of Patients for Radiation Therapy U. Amit,1 J.D. Goldstein,1 T. Davidson,2 M. Hahiashvili,2 E. Goshen,2 Y. Oksman,2 R. Berger,3 A. Saad,1 I. Sadetsky,1 B. Chikman,4