A phase III, multicenter study to assess the diagnostic performance and clinical impact of 18F-DCFPyL PET/CT in men with suspected recurrence of prostate cancer (CONDOR).

TPS5093 Background: Early and accurate detection of recurrent or metastatic prostate cancer remains an unmet diagnostic need for patient management. While agents for positron emission tomography (PET), such as 11C-choline and 18F-fluciclovine, have emerged as options for imaging recurrent prostate cancer, these agents are not specific for the disease. 18F-DCFPyL is a novel, low-molecular weight, PET radiopharmaceutical that binds selectively to prostate-specific membrane antigen with high affinity. In prior studies, 18F-DCFPyL PET/CT has shown reliable diagnostic performance in detecting metastatic or recurrent prostate cancer (Rowe Mol Imaging Biol 2016 18:411-19; Gorin J Urol 2018 1999:126-32). Methods: CONDOR is a phase 3, multicenter, open-label study designed to assess the diagnostic performance and clinical impact of 18F-DCFPyL PET/CT in men with suspected recurrent or metastatic prostate cancer. Approximately 200 patients are planned to be enrolled across 15 centers in the United States and Canada. Eligible patients ≥18 years of age must have histologically confirmed prostate adenocarcinoma, have rising PSA after definitive therapy, and negative or equivocal conventional imaging. A single 9 mCi (333 MBq) dose of 18F-DCFPyL is administered, followed by whole body PET/CT scan 1 hour later. The primary objective is to assess the correct localization rate (percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT and the composite truth standard, defined as either evaluable histopathology, informative correlative imaging, or PSA response after radiation therapy). Additional study objectives include safety and tolerability of 18F-DCFPyL, impact on intended treatment plans, detection rates and PPV of 18F-DCFPyL by region, and detection rates by baseline PSA. 18F-DCFPyL PET/CT results are centrally reviewed by independent readers blinded to all clinical and other imaging information. As of February 9, 2019, a total of 36 patients have been dosed in the study. Clinical trial information: NCT03739684.

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Detection Rate of 68Ga-PSMA Ligand PET/CT in Patients with Recurrent Prostate Cancer and Androgen Deprivation Therapy

Biomedicines ◽

10.3390/biomedicines8110511 ◽

2020 ◽

Vol 8 (11) ◽

pp. 511

Author(s):

Joachim Brumberg ◽

Melanie Beckl ◽

Alexander Dierks ◽

Andreas Schirbel ◽

Markus Krebs ◽

...

Keyword(s):

Prostate Cancer ◽

Androgen Deprivation Therapy ◽

Detection Rate ◽

Androgen Deprivation ◽

Disease Stage ◽

Whole Body ◽

Recurrent Prostate Cancer ◽

Detection Rates ◽

Psma Ligand ◽

Pet Ct

Prostate-specific membrane antigen (PSMA) ligand PET/CT enables the localization of tumor lesions in patients with recurrent prostate cancer, but it is unclear whether androgen deprivation therapy (ADT) influences diagnostic accuracy. The aim of this study was to evaluate the effect of ADT on the detection rate of 68Ga-PSMA ligand PET/CT. Thus, 399 patients with initial radical prostatectomy and 68Ga-PSMA ligand PET/CT during PSA relapse were retrospectively evaluated. Propensity score matching was used to create two balanced groups of 62 subjects who either did or did not receive ADT within six months before imaging. All 68Ga-PSMA ligand PET/CT were evaluated visually and with semiquantitative measures. The detection rate of tumor recurrence was significantly higher in the group with ADT (88.7% vs. 72.6%, p = 0.02) and improved with increasing PSA-levels in both groups. In subjects with pathological PET/CT and ADT, whole-body total lesion PSMA (p < 0.01) and PSMA-derived tumor volume (p < 0.01) were significantly higher than in those without ADT. More PSMA-positive lesions and higher PSMA-derived volumetric parameters in patients with ADT suggest that a better detection rate is related to a (biologically) more advanced disease stage. Due to high detection rates in patients with PSA-levels < 2 ng/mL, the withdrawal of ADT before PSMA ligand PET/CT cannot be recommended.

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Patterns of Recurrence, Detection Rates, and Impact of 18-F Fluciclovine PET/CT on the Management of Men With Recurrent Prostate Cancer

Urology ◽

10.1016/j.urology.2021.01.038 ◽

2021 ◽

Author(s):

Jamie Michael ◽

Amir H. Khandani ◽

Ramsankar Basak ◽

Hung-Jui Tan ◽

Trevor J. Royce ◽

...

Keyword(s):

Prostate Cancer ◽

Recurrent Prostate Cancer ◽

Detection Rates ◽

Pet Ct ◽

Patterns Of Recurrence

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Diagnostic performance of 18F-PSMA-1007 PET/CT in patients with biochemical recurrent prostate cancer

European Journal of Nuclear Medicine and Molecular Imaging ◽

10.1007/s00259-018-4089-x ◽

2018 ◽

Vol 45 (12) ◽

pp. 2055-2061 ◽

Cited By ~ 27

Author(s):

Kambiz Rahbar ◽

Ali Afshar-Oromieh ◽

Robert Seifert ◽

Stefan Wagner ◽

Michael Schäfers ◽

...

Keyword(s):

Prostate Cancer ◽

Diagnostic Performance ◽

Recurrent Prostate Cancer ◽

Pet Ct

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Clinical impact of 11C-Choline PET/CT in selection and outcome of salvage cryoablation in patients with recurrent prostate cancer after radiotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.276 ◽

2016 ◽

Vol 34 (2_suppl) ◽

pp. 276-276

Author(s):

Marleen Suzanne Vallinga ◽

Anthonius Breeuwsma ◽

Maxim Rybalov ◽

Jan Pruim ◽

Igle J. De Jong

Keyword(s):

Prostate Cancer ◽

Hormonal Therapy ◽

Biochemical Recurrence ◽

Clinical Impact ◽

Recurrent Prostate Cancer ◽

Choline Pet ◽

Pet Ct ◽

Psa Response ◽

The Impact

276 Background: Salvage cryoablation is an effective but toxic treatment for local recurrent prostate cancer after primary radiotherapy. To assess the location of recurrent prostate cancer, an 11C-choline PET/CT can be used. We studied the clinical impact of 11C-choline PET/CT on the choice for and the results of salvage cryoablation. Methods: A total of 141 patients with a biochemical recurrence (BCR according to ASTRO-Phoenix criteria) after radiotherapy, and thus candidates for salvage cryoablation, were included. Patients were re-staged with an 11C-choline PET/CT, complementary prostate biopsies, when indicated a pelvic lymph node dissection and/or additional imaging. Change in choice of therapy was defined as major (no salvage cryoablation because of metastases or lack of local recurrence on PET/CT), minor (local salvage treatment was performed, but different technique of after additional diagnostics) or none (salvage cryoablation was performed). The impact of selection of patients for cryoablation with PET/CT on outcome was measured by time from cryoablation to BCR (according to Astro-Phoenix), first distant metastasis and start of hormonal therapy. Results: In 71 of 141 patients (51%) a change in therapy was implemented because of the result of 11C-choline PET/CT. A major impact was observed in 48 (34%) patients. In 83 patients, a salvage cryoablation was performed (59%). 18% of this group showed no PSA response. Of the remaining patients with PSA response, 37% developed a BCR after mean 25.7 months. 47% of patients are still in remission after a mean follow-up of 43 months. In 16 of 83 patients (19%) metastases were proven after mean 55.4 months (SD 26.3). 15 patients started with hormonal therapy, mean 29.5 months (SD 20.1) after cryoablation. Conclusions: 11C-choline PET/CT showed a significant impact on selection for salvage cryoablation. The choice for local salvage therapy was abandoned in 34% of patients. Of the men who underwent a salvage cryoablation, 47% stayed free of biochemical recurrence during mean 43 months follow-up.

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Imaging metastatic prostate cancer with 18F-DCFBC PET/CT (DCFBC) and 18F-NaF PET/CT (NaF).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.6_suppl.231 ◽

2017 ◽

Vol 35 (6_suppl) ◽

pp. 231-231

Author(s):

Farhad Fakhrejahani ◽

Maria Liza Lindenberg ◽

Ethan S. Bargvall ◽

Esther Mena ◽

Baris Turkbey ◽

...

Keyword(s):

Prostate Cancer ◽

Soft Tissue ◽

Functional Imaging ◽

Metastatic Prostate Cancer ◽

Whole Body ◽

Inverse Association ◽

Non Invasive ◽

Imaging Results ◽

Pet Ct ◽

Antiandrogen Therapy

231 Background: Conventional imaging of advanced prostate cancer (computerized tomography and nuclear bone scintigraphy) is limited and indicates a need for a more specific molecular imaging probe. DCFBC is a radiolabeled PET agent that binds with high affinity to prostate specific membrane antigen (PSMA), which is overexpressed in almost all prostate cancers and through whole-body non-invasive functional imaging, may provide new information on the expression of PSMA. We compare the uptake of DCFBC in bone with respect to NaF PET/CT in metastatic prostate cancer patients. DCFBC has added capability to detect soft tissue metastasis whereas NaF is confined to secondary effects of bone disease. Methods: Subjects with known or suspected prostate cancer metastasis underwent DCFBC PET/CT imaging performed at 1 hour and 2 hours after IV bolus injection of 8 mCi of DCFBC. Patients also underwent a whole body NaF PET/CT scan within 3 weeks of DCFBC PET/CT to assess for bone metastases. Patients received 3 mCi of NaF IV bolus and then were imaged 1hour post injection. PSA levels and antiandrogen therapy status were obtained at the time of DCFBC imaging. Results: Fifteen patients have been preliminarily analyzed. PSA ranged from < .01 to 4379 ng/mL. NaF identified bone lesions in 10 patients but matching focal DCFBC uptake was only seen in 3 patients. DCFBC additionally showed lymph node metastasis in 1of these 3 patient. There were 5 patients without focal abnormal bone uptake on NaF or DCFBC. In this group, 4 of 5 patients had focal DCFBC uptake in lymph nodes or soft tissue lesions. Ten patients were on some form of androgen deprivation therapy (ADT). For those on ADT, 7 of 10 patients had positive findings on NaF, compared to 2 of 10 patients on DCFBC. Conclusions: DCFBC uptake in bone metastasis does not routinely correspond to focal NaF uptake which could be due to distinct mechanisms of tracer uptake and tumor biology. There is an inverse association in focal bone findings when comparing each tracer on antiandrogen therapy. Through whole-body non-invasive functional imaging and further study, DCFBC may prove useful in characterizing prostate cancer based on PSMA expression. Clinical trial information: NCT02190279.

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Whole-body diffusion-weighted magnetic resonance imaging (WB-DW-MRI) vs choline-positron emission tomography-computed tomography (choline-PET/CT) for selecting treatments in recurrent prostate cancer

Clinical & Translational Oncology ◽

10.1007/s12094-016-1563-4 ◽

2016 ◽

Vol 19 (5) ◽

pp. 553-561 ◽

Cited By ~ 10

Author(s):

A. J. Conde-Moreno ◽

G. Herrando-Parreño ◽

R. Muelas-Soria ◽

J. Ferrer-Rebolleda ◽

R. Broseta-Torres ◽

...

Keyword(s):

Magnetic Resonance Imaging ◽

Prostate Cancer ◽

Computed Tomography ◽

Emission Tomography ◽

Whole Body ◽

Recurrent Prostate Cancer ◽

Resonance Imaging ◽

Positron Emission ◽

Pet Ct ◽

Weighted Magnetic Resonance Imaging

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Detection rates of recurrent prostate cancer: 68Gallium (Ga)-labelled prostate-specific membrane antigen versus choline PET/CT scans. A systematic review

Therapeutic Advances in Urology ◽

10.1177/1756287218815793 ◽

2019 ◽

Vol 11 ◽

pp. 175628721881579 ◽

Cited By ~ 6

Author(s):

Masood Moghul ◽

Bhaskar Somani ◽

Tim Lane ◽

Nikhil Vasdev ◽

Brian Chaplin ◽

...

Keyword(s):

Prostate Cancer ◽

Systematic Review ◽

Ct Scans ◽

Prostate Specific Membrane Antigen ◽

Recurrent Prostate Cancer ◽

Detection Rates ◽

Psma Pet ◽

Pet Ct ◽

Significant Difference ◽

Specific Membrane

Background: The aim of this work was to assess the use of prostate-specific membrane antigen (PSMA)-labelled radiotracers in detecting the recurrence of prostate cancer. PSMA is thought to have higher detection rates when utilized in positron emission tomography (PET)/computed tomography (CT) scans, particularly at lower prostate-specific antigen (PSA) levels, compared with choline-based scans. Methods: A systematic review was conducted comparing choline and PSMA PET/CT scans in patients with recurrent prostate cancer following an initial curative attempt. The primary outcomes were overall detection rates, detection rates at low PSA thresholds, difference in detection rates and exclusive detection rates on a per-person analysis. Secondary outcome measures were total number of lesions, exclusive detection by each scan on a per-lesion basis and adverse side effects. Results: Overall detection rates were 79.8% for PSMA and 66.7% for choline. There was a statistically significant difference in detection rates favouring PSMA [OR (M–H, random, 95% confidence interval (CI)) 2.27 (1.06, 4.85), p = 0.04]. Direct comparison was limited to PSA < 2 ng/ml in two studies, with no statistically significant difference in detection rates between the scans [OR (M–H, random, 95% CI) 2.37 (0.61, 9.17) p = 0.21]. The difference in detection on the per-patient analysis was significantly higher in the PSMA scans ( p < 0.00001). All three studies reported higher lymph node, bone metastasis and locoregional recurrence rates in PSMA. Conclusions: PSMA PET/CT has a better performance compared with choline PET/CT in detecting recurrent disease both on per-patient and per-lesion analysis and should be the imaging modality of choice while deciding on salvage and nonsystematic metastasis-directed therapy strategies.

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