Leah Lawrence

	Diagnostic magnetic resonance imaging (MRI) strategies for the diagnosis of prostate cancer should be considered prior to biopsy of suspicious lesions, according to the results of a study published online in 

	Compared with transrectal ultrasound-guided biopsies, MRI diagnostic exams followed by MRI-guided biopsies yielded net health benefits well within the commonly accepted threshold for cost-benefit ratios.

	“We believe that the adoption of these strategies could be very beneficial to the patient and the health care system,” Vikas Gulani, MD, PhD, of University Hospitals Case Medical Center, Cleveland, told 

 on behalf of him and his partner Lee E. Ponsky, MD. “The patient benefits with fewer biopsy-related complications and more accurate diagnosis and triaging of disease. We hope this study will provide sufficient evidence that will allow MRI prior to biopsy to be incorporated into management algorithms.”

 diagnosis and treatment is quite primitive compared to other cancers. In 2017, clinicians still biopsy patients without a predetermined imaged based focus to target.

	“This is not true anywhere else in the body. We all operate from the assumption that the only real way we presently have of ‘seeing’ the cancer non-invasively-MRI-is not cost-effective for all comers,” Dr. Gulani said.

	Dr. Gulani and colleagues designed this study to test this assumption, and expected to find that obtaining an MRI before biopsy was not cost-effective.

	They developed a decision analysis model for biopsy-naive men recommended for a prostate biopsy based on abnormal digital rectal examination or elevated PSA levels. They evaluated three strategies: standard transrectal ultrasound guided biopsy, diagnostic MRI followed by MRI-targeted biopsy with no biopsy performed if MRI was negative, and diagnostic MRI followed by MRI-targeted biopsy with a standard biopsy performed when MRI was negative.

	“Ultrasound allows visualization of the prostate, but not direct visualization of a potential cancer. Transrectal ultrasound-guided biopsies involve the operator visualizing the prostate via a transrectal approach, and then obtaining a number of biopsies from the prostate by systematically sampling parts of the gland over multiple locations,” Dr. Gulani said.

Next: Three MRI-guided biopsy strategies evaluated

	In contrast, MRI-guided approaches use MRI to identify a focus of suspicion, and then obtain targeted biopsies from these suspicious foci. In the study, the authors evaluated three MRI-guided biopsy strategies: cognitive guidance, MRI-ultrasound fusion, or in-gantry MRI biopsy. These three strategies are of increasing complexity and cost, and also increasing accuracy.

	The authors obtained ratios of net health benefits added by the technology (quality adjusted life years [QALYs]) and associated costs. They then applied commonly accepted criteria for cost for each QALY; methods meeting these criteria are considered cost-effective.

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	They found that non-contrast MRI followed by cognitively-guided MR biopsy was the most cost-effective approach, yielding an additional net health benefit of 0.198 QALYs compared with standard biopsy. Non-contrast MRI followed by in-gantry MR biopsy led to the highest net health benefit of 0.251 additional QALYs compared with standard biopsy.

	“Both results were surprising. This will strengthen the collaboration between radiologists and urologists. The radiology community contributes to a more effective way of managing patients. The urology community can better counsel patients regarding appropriate treatment options for aggressive disease, while placing indolent cancers in active surveillance protocols,” Dr. Gulani said.

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Diagnostic magnetic resonance imaging strategies for the diagnosis of prostate cancer should be considered prior to biopsy of suspicious lesions, according to a recent study.

MRI-guided PCa detection strategies found cost-effective

 screening preferred education about prostate cancer prior to undergoing screening, and thought the use of an informed decision-making model was beneficial, researchers reported at the Genitourinary Cancers Symposium in Orlando, FL.

	According to first author Puneet Dhillon, DO, prostate cancer screening is a controversial topic and the 2012 U.S. Preventive Services Task Force guidelines do not support prostate cancer screening. However, prostate cancer is the most common cancer in American men, except for skin cancer, and the second leading cause of cancer-related death in men. (At press time, the USPSTF released an updated draft recommendation supporting individualized decision-making in men ages 55-69 years.)

Dr. DhillonThe incidence and mortality from prostate cancer is higher in African-American men compared to that in Caucasian men, and African-American men are often diagnosed at a more advanced disease stage and have a poorer 5-year survival rate. This puts them in a higher risk category for being diagnosed with prostate cancer. Health-education programs and culturally appropriate educational outreach efforts, especially targeted for high-risk groups, are needed to reduce these disparities,” said Dr. Dhillon, hematology/oncology fellow at Providence-Providence Park Hospital, Southfield, MI, who worked on the study with Samir Abraksia, MD, of Cleveland Clinic, and co-authors.

18F-choline PET/CT detects PCa recurrences early

	The process of using informed decision-making is included in the guidelines of most organizations including the AUA, the European Association of Urology, and the American College of Preventive Medicine.

	“Clinical investigation has found that physicians find it difficult to provide comprehensive, unbiased education about screening to patients,” Dr. Dhillon told 

. “Empowering men to participate in decision-making in the face of uncertainty about prostate screening represents a major challenge.”

	With this study, Dr. Dhillon and co-authors wanted to examine whether informed decision-making guidelines in a large high-risk group setting can improve knowledge on prostate cancer and screening decisions, and whether these programs ultimately benefit patients.

	The intervention included 106 participants in a 1-day outreach event. Participants were exposed to a 20-minute PowerPoint presentation that was scripted to facilitate consistency and minimize bias affecting screening decision, and was created according to information and guidelines from the American Cancer Society. Patients were given a 15-question pre- and post-test and were offered screening using PSA and digital rectal exam (DRE).

	“Most participants favored informed decision making and education before being given the choice to be screened or not,” Dr. Dhillon said.

	Seventy-five percent of participants found the intervention to be beneficial in making an informed decision about prostate cancer screening, including that the program was “very helpful” on a 5-point Likert scale. In addition, 75% of participants showed improvement in prostate cancer knowledge in the post- compared with the pre-test 

	After participating in the informed decision-making intervention, 86% of participants favored undergoing screening; of those who favored screening, 92% were African-American. Only 18% of participants said they would have preferred undergoing screening without the informed decision-making process.

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	There were 14 participants with abnormal findings; 13 with abnormal PSA, five with abnormal DRE, and four with abnormal PSA and DRE.

	According to Dr. Dhillon, these results demonstrate that “creating a model in which guidelines-based prostate cancer screening can be effectively and practically implemented in high-risk communities would empower men to actively be a part of this process.”

	The authors are currently working to create a model that is effective in reaching high-risk populations for prostate cancer in larger volumes.

	Dr. Dhillon has received travel, accommodations, and expenses from Genentech. Several study co-authors have a financial or other relationship with pharmaceutical companies.

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Participants in an outreach event for prostate cancer screening preferred education about prostate cancer prior to undergoing screening, and thought the use of an informed decision-making model was beneficial, researchers reported at the Genitourinary Cancers Symposium in Orlando, FL.

Most men prefer informed decision-making for PCa

 with an 18F-choline positron emission tomography/computed tomography–detected recurrence were potentially salvageable with local therapy or metastasis-directed therapy (MDT), according to results of the screening phase of the phase II STOMP randomized trial.

Dr. Ost“The majority of prostate cancer recurrences are eligible for local therapies and should not be considered palliative,” first author Piet Ost, MD, PhD, radiation oncologist and senior clinical investigator of the Research Foundation, Flanders, Belgium, told 

Findings were presented at the Genitourinary Cancers Symposium in Orlando, FL.

			According to Dr. Ost, with the introduction of choline and prostate-specific membrane antigen PET-CT, clinicians are seeing prostate cancer recurrences earlier, at the first signs of PSA relapse.

			“Many of these recurrences are limited in number and location, called oligorecurrences. More aggressive local therapies-metastasis-directed therapy-have been suggested for these recurrences instead of systemic treatment, but it is unclear from literature what the proportion of oligorecurrent patients is,” Dr. Ost said.

			The current study aimed to describe the anatomic patterns of prostate cancer recurrence after local therapy and reports the proportion of patients potentially eligible for MDT, defined here as those patients with up to three metastatic lesions.

			The trial included 229 patients who underwent 18F-choline PET/CT for biochemical prostate cancer recurrence for potential inclusion in the randomized STOMP trial. In STOMP, patients will be randomly assigned to active surveillance or MDT. Eligible patients included those with biochemical recurrence, up to three extracranial metastases, and testosterone greater than 50 ng/mL.

			Based on the screening, patterns of recurrence were classified as local (prostate or prostate bed), distant (N1 or M1b/b/c), or a combination of both.

			After screening, the authors identified 208 patients (91%) with a recurrence and 21 patients (9%) with no recurrence. Of those men with recurrence, 10% had a local recurrence and 81% had a distant recurrence. The most common site of recurrence was the lymph nodes (30%), followed by the prostate (11%), bone (18%), and visceral metastases (4%), or a combination of these sites (37%).

			Among the patients with distant recurrence, 57% were considered oligorecurrent: 25% of patients had one lesion, 17% had two lesions, and 15% had three lesions.

			Seventy-four percent of the patients were considered to have salvageable disease (three or fewer metastases). Patients with salvageable disease had lower PSA levels 

<.001) compared with patients with non-salvageable disease. Twenty-seven percent of men with oligorecurrent prostate cancer agreed to be randomized in the STOMP trial.

			Based on the results of this study, Dr. Ost said, “Early screening with 18F-choline PET-CT is able to detect clinical recurrences early and identifies patients eligible for metastasis-directed therapy.”

			Dr. Ost is a consultant/adviser for Ferring and has received travel, accommodations, and expenses from Ferring and Ipsen. His institution has received research funding from Ferring, Merck, and Novartis.

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Three out of four patients with prostate cancer with an 18F-choline positron emission tomography/computed tomography–detected recurrence were potentially salvageable with local therapy or metastasis-directed therapy (MDT), according to results of the screening phase of the phase II STOMP randomized trial.

	Clinicians may soon be able to improve the risk stratification of men with prostate cancer with the help of a genomic classifier or a biopsy-based reverse transcription polymerase chain reaction (RT-PCR) assay, according to the results of two studies presented at the Genitourinary Cancers Symposium in Orlando, FL.

	In the first study,presented by Paul L. Nguyen, MD, the genomic classifier Decipher was able to accurately predict metastasis and prostate-cancer specific mortality (PCSM) from a needle biopsy in men with intermediate- and high-risk prostate cancer.

	“The Decipher classifier obtained from biopsy samples was associated with distant metastases and prostate-cancer specific mortality after radical prostatectomy or radiation therapy and a short course of hormone therapy. It provided significant prognostic information beyond clinical variables alone,” said Dr. Nguyen, associate professor of radiation oncology at Harvard Medical School, Boston.

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	Decipher is a 22-gene RNA-based signature developed to predict risk of metastasis after radical prostatectomy. Here, Dr. Nguyen and co-authors conducted a multi-institutional study of Decipher aimed at evaluating whether it could predict metastasis and prostate cancer-specific mortality earlier in the treatment process using needle biopsy tumor specimens.

	The study included 175 patients who were treated with first-line radical prostatectomy (43%) or radiation therapy plus androgen deprivation therapy (57%). All patients had genomic expression profiles available.

	The majority of the men in the study (85%) had intermediate- or high-risk disease. With a median follow-up of 6 years, 32 patients developed metastases and 11 patients died of prostate cancer.

	Results from the study showed that the Decipher classifier scores did stratify for risk of metastasis. The risk for 5-year metastasis by Decipher score was 23.4% in high-risk patients, 9.3% in intermediate-risk patients, and 5.0% in low-risk patients.

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	“This multivariable model shows that the classifier does add valuable prognostic information to the clinical variables when predicting for distant metastases even when you adjust for PSA, Gleason score T category, and treatment type,” Dr. Nguyen said.

	In both the univariable and multivariable analyses, the Decipher score was the only variable that was significant for distant metastases when accounting for the other clinical variables.

	The Decipher score was also found to improve the C-index when predicting for distant metastases. Using National Comprehensive Cancer Network risk groups, the C-index was 0.66; however, when using NCCN risk groups added to the Decipher score, the C-index was 0.75.

	“It enhances our ability to decide which patient are going to develop metastases,” Dr. Nguyen said.

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	Finally, Decipher also predicted for PCSM (HR=1.57 per 10% increase in Decipher score; 95% CI: 1.07-.240; 

=.02). The risk for 5-year prostate cancer-specific mortality by Decipher score was 9.4% in high-risk patients, 0% in intermediate-risk patients, and 0% in low-risk patients.

	The second study examined the use of the Oncotype DX prostate cancer test as a predictor of biochemical recurrence in men with prostate cancer treated with radical prostatectomy in a community setting. The test’s results are provided as a 17-gene Genomic Prostate Score (GPS).

	The biopsy-based RT-PCR assay had previously been validated as an independent predictor of adverse surgical pathology and biochemical recurrence in men with low-risk and low-volume disease. The updated data, presented by Stephen K. Van Den Eeden, PhD, a senior investigator at Kaiser Permanente Northern California, Oakland, showed that GPS was also associated with biochemical recurrence independent of other clinical factors in surgically treated men with prostate cancer.

	“The study confirmed that increases in the GPS from biopsy samples are associated with an increased risk of biochemical occurrence among men who were treated with surgery,” Dr. Van Den Eeden told 

	The study included men treated with radical prostatectomy and diagnosed with NCCN very low-, low-, intermediate-, and high-risk prostate cancer between 1995 and 2010 in the Kaiser Permanente Northern California network. Archival biopsy tissue was assayed to yield a GPS (scale 0-100).

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	Tumor tissue was retrieved for 334 patients, 279 met all the study eligibility requirements, and 259 generated a valid GPS. There were 117 biochemical recurrence events.

	Data from a univariable analysis showed that the GPS was strongly associated with biochemical recurrence (hazard ratio per 20 GPS units=2.5; 

<.0001). After adjusting for PSA, clinical T stage, and central biopsy Gleason score, the hazard ratio was 2.1 

	“The information from the GPS for the properly targeted patient can provide additional information regarding treatment decisions,” Dr. Van Den Eeden said. “The GPS, if used, needs to be part of the overall picture that takes into account the clinical factors already available, such as the diagnostic PSA level, Gleason score, and stage.”

	Dr. Nguyen is a consultant/adviser for Ferring, GenomeDx, and Medivation and receives research funding from Astellas Pharma. Several of his co-authors are consultant/advisers for or are employees of GenomeDx, and several have a financial or other relationship with pharmaceutical companies. Dr. Van Den Eeden has received research funding from Abbott Molecular, Genomic Health, and Takeda. Several of his co-authors are employees of Genomic Health. One of his co-authors has received research funding from several pharmaceutical companies.

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Clinicians may soon be able to improve the risk stratification of men with prostate cancer with the help of a genomic classifier or a biopsy-based reverse transcription polymerase chain reaction assay, according to the results of two studies presented at the Genitourinary Cancers Symposium in Orlando, FL.

Author | Leah Lawrence

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