A novel molecular imaging technique demonstrated higher diagnostic accuracy than conventional imaging among a cohort of men with high-risk prostate cancer, according to results of a randomized phase 3 study published in The Lancet.
“Taken together, our findings indicate that prostate-specific membrane antigen PET-CT scans offer greater accuracy than conventional imaging and can better inform treatment decisions. We recommend that clinical guidelines should be updated to include prostate-specific membrane antigen PET/CT as part of the diagnostic pathway for men with high-risk prostate cancer,” Michael S. Hofman, MBBS, FRACP, FAANMS, professor of nuclear medicine at Peter McCallum Cancer Centre in Melbourne, Australia, said in a press release.
Standard-of-care imaging with CT and bone scan has insufficient sensitivity and specificity for detection of nonlocalized prostate cancer, researchers wrote.
In the multicenter, two-arm, prospective proPSMA study, Hofman and colleagues assessed whether gallium-68 prostate specific-membrane antigen (PSMA)-11 PET-CT — an imaging technique that delivers detailed body scans of patients as it detects prostate cancer cells — could improve accuracy and affect treatment management.
A novel molecular imaging technique demonstrated higher diagnostic accuracy than conventional imaging among a cohort of men with high-risk prostate cancer
Source: Adobe
The researchers randomly assigned 300 men (median age, 69 years; interquartile range [IQR], 63-73.5) with biopsy-proven prostate cancer and high-risk features across 10 hospitals in Australia to conventional imaging (n = 152) or PSMA-11 PET-CT (n = 148).
Accuracy of first-line imaging for identifying either pelvic nodal or distant metastatic disease, defined by the receiver operating curve using a predefined reference standard including histopathology, imaging and biochemistry at 6-month follow-up, served as primary outcome.
Men underwent first-line imaging within 21 days after randomization and crossed over to the alternate imaging group unless three or more distant metastases were found. Five men dropped out of the study or did not have follow-up data available.
All study participants received a second round of medical imaging at 6-month follow-up. Researchers used results of scans, biopsies and changes in blood tests to confirm tumor spread.
Eighty-seven men (30%) had pelvic nodal or distant metastatic disease.
Researchers observed greater accuracy with the novel imaging technique compared with conventional imaging (92% vs. 65%;P < .0001). In addition, PSMA-11 PET-CT was associated with greater sensitivity (85% vs. 38%) and specificity (98% vs. 91%).
Results of subgroup analyses showed superiority of PSMA-11 PET-CT vs. conventional imaging among men with pelvic nodal metastases (area under the curve, 91% vs. 59%) and men with distant metastases (AUC, 95% vs. 74%).
Compared with PSMA-11 PET-CT, conventional imaging was associated with fewer management changes (28% vs. 15%; P = .008) and more equivocal findings (7% vs. 23%).
Conventional imaging exposed men to a radiation dose of 19.2 mSv compared with 8.4 mSv among men who underwent PSMA-11 PET-CT.
Researchers noted that 27% of men in the PSMA-11 PET-CT group who underwent second-line imaging had their treatment plans changed, compared with only 5% of men who underwent conventional imaging.
Investigators cautioned that a full cost analysis is needed to determine the feasibility of widespread PSMA-11 PET-CT use. However, they recommended replacement of conventional imaging with the new technique for certain men with high-risk prostate cancer.
Such new imaging modalities with improved sensitivity in detection of small-volume metastases present both challenges and opportunities, according to a related editorial by Caroline Moore, professor of urology at University College London.
“In particular, when men test negative on conventional imaging and gallium-68 PSMA-11 PET-CT shows small-volume metastatic disease, what should we do?” Moore wrote. “Hofman and colleagues recognized this challenge and should be commended for explicitly acknowledging on the patient information sheet the uncertainty that arises from novel imaging data, and that the effect of any change in management on long-term outcomes is unknown.” – by Jennifer Southall
Disclosures: The study was funded by Movember and Prostate Cancer Foundation of Australia. Hofman reports grants from Movember, the Peter MacCallum Foundation, Prostate Cancer Foundation of Australia, the U.S. Department of Defense and the Victorian Cancer Agency, as well as personal fees and nonfinancial support from Ipsen, Jannsen and Sanofi Genzyme outside of the submitted work. Please see the study for all authors’ relevant financial disclosures. Moore reports speaker fees from Astellas and Janssen; proctoring fees from Sonablate; and advisory board roles with Genomic Health and Steba Biotech.
A novel molecular imaging technique demonstrated higher diagnostic accuracy than conventional imaging among a cohort of men with high-risk prostate cancer, according to results of a randomized phase 3 study published in The Lancet.
“Taken together, our findings indicate that prostate-specific membrane antigen PET-CT scans offer greater accuracy than conventional imaging and can better inform treatment decisions. We recommend that clinical guidelines should be updated to include prostate-specific membrane antigen PET/CT as part of the diagnostic pathway for men with high-risk prostate cancer,” Michael S. Hofman, MBBS, FRACP, FAANMS, professor of nuclear medicine at Peter McCallum Cancer Centre in Melbourne, Australia, said in a press release.
Standard-of-care imaging with CT and bone scan has insufficient sensitivity and specificity for detection of nonlocalized prostate cancer, researchers wrote.
In the multicenter, two-arm, prospective proPSMA study, Hofman and colleagues assessed whether gallium-68 prostate specific-membrane antigen (PSMA)-11 PET-CT — an imaging technique that delivers detailed body scans of patients as it detects prostate cancer cells — could improve accuracy and affect treatment management.
A novel molecular imaging technique demonstrated higher diagnostic accuracy than conventional imaging among a cohort of men with high-risk prostate cancer
Source: Adobe
The researchers randomly assigned 300 men (median age, 69 years; interquartile range [IQR], 63-73.5) with biopsy-proven prostate cancer and high-risk features across 10 hospitals in Australia to conventional imaging (n = 152) or PSMA-11 PET-CT (n = 148).
Accuracy of first-line imaging for identifying either pelvic nodal or distant metastatic disease, defined by the receiver operating curve using a predefined reference standard including histopathology, imaging and biochemistry at 6-month follow-up, served as primary outcome.
Men underwent first-line imaging within 21 days after randomization and crossed over to the alternate imaging group unless three or more distant metastases were found. Five men dropped out of the study or did not have follow-up data available.
All study participants received a second round of medical imaging at 6-month follow-up. Researchers used results of scans, biopsies and changes in blood tests to confirm tumor spread.
Eighty-seven men (30%) had pelvic nodal or distant metastatic disease.
Researchers observed greater accuracy with the novel imaging technique compared with conventional imaging (92% vs. 65%;P < .0001). In addition, PSMA-11 PET-CT was associated with greater sensitivity (85% vs. 38%) and specificity (98% vs. 91%).
Results of subgroup analyses showed superiority of PSMA-11 PET-CT vs. conventional imaging among men with pelvic nodal metastases (area under the curve, 91% vs. 59%) and men with distant metastases (AUC, 95% vs. 74%).
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Compared with PSMA-11 PET-CT, conventional imaging was associated with fewer management changes (28% vs. 15%; P = .008) and more equivocal findings (7% vs. 23%).
Conventional imaging exposed men to a radiation dose of 19.2 mSv compared with 8.4 mSv among men who underwent PSMA-11 PET-CT.
Researchers noted that 27% of men in the PSMA-11 PET-CT group who underwent second-line imaging had their treatment plans changed, compared with only 5% of men who underwent conventional imaging.
Investigators cautioned that a full cost analysis is needed to determine the feasibility of widespread PSMA-11 PET-CT use. However, they recommended replacement of conventional imaging with the new technique for certain men with high-risk prostate cancer.
Such new imaging modalities with improved sensitivity in detection of small-volume metastases present both challenges and opportunities, according to a related editorial by Caroline Moore, professor of urology at University College London.
“In particular, when men test negative on conventional imaging and gallium-68 PSMA-11 PET-CT shows small-volume metastatic disease, what should we do?” Moore wrote. “Hofman and colleagues recognized this challenge and should be commended for explicitly acknowledging on the patient information sheet the uncertainty that arises from novel imaging data, and that the effect of any change in management on long-term outcomes is unknown.” – by Jennifer Southall
Disclosures: The study was funded by Movember and Prostate Cancer Foundation of Australia. Hofman reports grants from Movember, the Peter MacCallum Foundation, Prostate Cancer Foundation of Australia, the U.S. Department of Defense and the Victorian Cancer Agency, as well as personal fees and nonfinancial support from Ipsen, Jannsen and Sanofi Genzyme outside of the submitted work. Please see the study for all authors’ relevant financial disclosures. Moore reports speaker fees from Astellas and Janssen; proctoring fees from Sonablate; and advisory board roles with Genomic Health and Steba Biotech.
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Novel technique outperforms traditional imaging for high-risk prostate cancer - Healio
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