FDA Approves Axumin to Detect Recurrent Prostate Cancer


“The FDA today approved Axumin, an injectable radioactive diagnostic agent used to detect recurrent prostate cancer.

“The agent is indicated for PET imaging in men who have suspected prostate cancer recurrence based on elevated PSA levels following treatment.

“The FDA based its decision on results of two studies that evaluated the safety and efficacy of Axumin (Blue Earth Diagnostics). One study compared 105 Axumin scans to histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in men suspected of having prostate cancer recurrence. In the second study, researchers evaluated 96 Axumin scans with C11 choline scans in patients with a median PSA of 1.44 ng/mL.”

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PET Imaging Detects Fast-Growing Prostate Cancer

“A molecular imaging biomarker is able to detect fast-growing primary prostate cancer and distinguish it from benign prostate lesions, addressing an unmet clinical need. The new research, published in the July 2015 issue of The Journal of Nuclear Medicine, is significant for patients with suspected prostate cancer that has not been confirmed by standard biopsy.

” ‘We were able to demonstrate in our research that PSMA PET imaging was more specific than MR imaging for detection of clinically significant high-grade prostate cancer lesions, and importantly was able to distinguish benign prostate lesions from primary prostate cancer, currently a difficult diagnostic imaging task,’ stated Steven P. Rowe, MD, PhD, resident at Johns Hopkins Medical Institutions in Baltimore, Md. ‘Additionally, this work demonstrated a direct correlation between PSMA PET radiotracer activity in prostate cancer and prostate adenocarcinoma aggressiveness (Gleason score).’ “

Reprogramming Metabolism with Metformin Improves Tumor Oxygenation and Radiotherapy Response

“Purpose: Tumor hypoxia is a negative prognostic factor in multiple cancers, due in part to its role in causing resistance to radiotherapy. Hypoxia arises in tumor regions distal to blood vessels as oxygen is consumed by more proximal tumor cells. Reducing the rate of oxygen consumption is therefore a potential strategy to reduce tumor hypoxia. We hypothesized that the anti-diabetic drug metformin, which reduces oxygen consumption through inhibition of mitochondrial complex I, would improve radiation response by increasing tumor oxygenation. Experimental Design: Tumor hypoxia was measured in xenografts before and after metformin treatment using 2-nitroimidazole hypoxia markers quantified by immunohistochemistry (IHC), flow cytometry and positron emission tomography (PET)-imaging. Radiation response was determined by tumor growth delay and clonogenic survival in xenografts with and without administration of metformin. The impact of metformin use on outcome was assessed in 504 localized prostate cancer patients treated with curative-intent, image-guided radiotherapy (IGRT) from 1996 to 2012. Three-year biochemical relapse-free rates were assessed using the Kaplan-Meier method. Results: Metformin treatment significantly improved tumor oxygenation in two xenograft models as measured by IHC, flow cytometry and PET imaging. Metformin also led to improved radiotherapy responses when mice were administered metformin immediately prior to irradiation. Clinically, metformin use was associated with an independent and significant decrease in early biochemical relapse rates (p=0.0106). Conclusion: Our data demonstrate that metformin can improve tumor oxygenation and response to radiotherapy. Our study suggests that metformin may represent an effective and inexpensive means to improve radiotherapy outcome with an optimal therapeutic ratio.”

In Vivo Imaging of Prostate Cancer Using [68Ga]-Labeled Bombesin Analog BAY86-7548

“Purpose: A novel [68Ga]-labeled DOTA-4-amino-1-carboxymethyl-piperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2 peptide (BAY86-7548) having high affinity to bombesin receptor subtype 2 to detect primary and metastatic prostate carcinoma (PCa) using PET/CT was synthesized and evaluated for prostate cancer (PCa). Experimental Design: In this first human study with BAY86-7548, fourteen men scheduled for radical prostatectomy (n=11) or with biochemical recurrence after surgery or hormonal therapy (n=3) were enrolled. The patients received an intravenous injection of BAY86-7548 followed by over 60-minute dynamic imaging of prostate gland (n=10) and/or subsequent whole-body imaging (n=14). The visual assessment of PET/CT images included evaluation of intraprostatic (12 subsextants) and pelvic nodal uptake of BAY86-7548 in 11 surgical patients and detection of potential metastatic foci in all patients. In patients with biochemical recurrence, results were compared to those of either [11C]-acetate (n=2) or [18F]-fluoromethylcholine (n=1) PET/CT…Conclusions: BAY86-7548 PET/CT is a promising molecular imaging technique for detecting intraprostatic PCa.”

FDA Gives Radium-223 Priority Review Status

Radium Ra 223 Dichloride will be considered as a treatment for patients who have castration-resistant prostate cancer with bone metastases under the FDA’s priority review program. The filing is based on the 922 patient phase III ALSYMPCA trial, of radium-223 plus current standard of care, or placebo plus current standard of care.

ASCO GU 2013: C-11 Choline PET for Biochemical Recurrence in Prostate Cancer: Answer or Just Catalyst for Change?

The recent approval by the U.S. Food and Drug Administration (FDA) for the production of C-11 choline at Mayo Clinic for PET imaging in patients with biochemical recurrence (BCR) of prostate cancer has generated intense interest in the biomedical molecular imaging community. The main reason for this enthusiasm is that this is the first approval of a PET agent specifically for detecting sites of recurrence in prostate cancer, a highly prevalent disease for which conventional imaging tools have proven inadequate.