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Clinical Focus

Videos

Dr. Declan G. Murphy discusses results from the phase 3 proPSMA study of Ga 68 PSMA-11 in patients with high-risk prostate cancer. 

Dr. Declan G. Murphy on results of the proPSMA study of Ga 68 PSMA-11 in prostate cancer

Articles

The agency approved the first PSMA-targeted PET imaging drug for men with prostate cancer.

FDA approves Gallium 68 PSMA-11 for prostate cancer

EMPIRE-1 is the first randomized trial to demonstrate an improvement in failure-free survival with treatment based on advanced molecular imaging versus conventional imaging in men with recurrent prostate cancer.

Radiotracer fluciclovine (18F) PET leads to improved cancer control in recurrent prostate cancer

The imaging modality detected nodal metastasis with a sensitivity of 55.3% and a specificity of 84.8% in each patient.

18F-fluciclovine PET/CT accurately detects metastases in high-risk prostate cancer

The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom 177Lu-PSMA-617 is indicated.

FDA approves new indication for Illuccix in metastatic prostate cancer

Once patients had a PSA level of 0.25 ng/mL or higher, the risk of mortality increased by approximately 50%.

PSMA-PET may lead to treatment delays that unintentionally harm patients with prostate cancer

The phase 1 PROPELLER trial assessed the safety and efficacy of 64Cu-SAR-bisPSMA, and compared the imaging agent with 68Ga-PSMA-11 PET.

Imaging agent 64Cu-SAR-bisPSMA effective in treatment-naive prostate cancer

The data come from a sub-analysis of the pivotal phase 3 CONDOR trial of the PSMA-targeted radiopharmaceutical piflufolastat F 18 in men with suspected recurrence of prostate cancer.

Analysis underscores value of piflufolastat F 18 in recurrent prostate cancer with low PSA levels

“I clearly think that this agent improves the identification of clear cell kidney cancer compared with any metric on any cross-sectional imaging study to date," says Brian M. Shuch, MD.

Clear cell RCC imaging agent 89Zr-DFO-girentuximab demonstrates accuracy

, a urologists at Chesapeake Urology Research Associates, Towson, Maryland, discusses findings from the phase 3 SPOTLIGHT trial that support the clinical utility of theradiohybrid PSMA-PET imaging agent 18F-rhPSMA-7.3 PET for a broad range of patients with recurrent prostate cancer.

The multicenter, single-arm SPOTLIGHT trial (NCT04186845) enrolled male patients who were at least 18 years of age and received prior curative intent treatment for localized prostate cancer. Patients were required to have elevated PSA levels that could indicate biochemical recurrence and be eligible for salvage therapy.

Among all patients in the trial’s efficacy evaluable population, 18F-rhPSMA-7.3 detection rates were high across all blinded central readers, with a patient-level detection rate of over 80% by majority read. The analysis from SPOTLIGHT trial that Lowentritt discusses in this video examined the impact of baseline PSA level, PSA doubling time, Gleason score, and prior therapy on 18F-rhPSMA-7.3 detection rates. In the video, Lowentritt says that, “There was an overall very high level of performance and detection rates across all of those subgroups.”

What we know about patients that recur is that we do see all different patterns of recurrence, some that happen more quickly and some that happened over more of a time period. We also find the patients at different points, both specifically with their PSA levels, as well as their PSA doubling time, or they may have had a history of higher or lower grade cancer at their initial diagnosis. So, we looked at all of these in the SPOTLIGHT trial patients—we looked at the PSA level, we looked at the PSA doubling time, we looked at what their initial Gleason score was, whether they had had surgery initially or radiation initially, and there was an overall very high level of performance and detection rates across all of those subgroups. There certainly is a component of the absolute PSA level where you see the higher the PSA, the higher the detection rate, but in the entire cohort that was studied where we can assess detection rate data, using a majority read of blinded central readers, 83% of patients that were imaged had disease detected had a detection of disease. So, all of this was very positive and shows the value of having this novel PET agent in identifying sites of recurrence.

The transcript has been edited for clarity.

Benjamin Lowentritt, MD, discusses how the phase 3 SPOTLIGHT trial showed the efficacy of the PSMA-PET imaging agent 18F-rhPSMA-7.3 PET across a variety of subgroups in prostate cancer. 

Dr. Lowentritt on broad efficacy of 18F-rhPSMA-7.3 PET in prostate cancer

, discusses the international, prospective, open-label, randomized, phase 3 PSMAddition study (NCT04720157),

Lu-psma-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) in combination with standard of care (SOC) versus SOC alone in in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC). SOC is androgen-deprivation therapy (ADT) plus an androgen receptor pathway inhibitor. The enrollment goal for the trial is over 1100 patients. The primary study end point is radiographic progression-free survival, with the key secondary end point being overall survival.

Morgans is a member, faculty of medicine, Harvard Medical School, and medical director, Survivorship Program, Dana-Farber Cancer Institute.

One of the areas of really high interest in prostate cancer is radiopharmaceutical use and there is a study now called PSMAddition, which is combining ADT and 

Lu-PSMA-617 along with our androgen receptor signaling inhibitors to see if that triplet combination is better than ADT and an androgen receptor signaling inhibitor alone in patients with mHSPC. I think that's of high interest because we just really are getting to use 

Lu-PSMA-617 for some of the first patients and standard of care use at this point in time and so having the opportunity to move that agent from the very advanced metastatic castration-resistant prostate cancer setting into that hormone-sensitive setting is really exciting and I think really hopeful, because we know that that's a relatively well-tolerated treatment for most patients, and in combination with an AR signaling inhibitor is probably still going to be pretty well tolerated. So that study is one of the most highly anticipated of all of the metastatic hormone-sensitive setting trials that we have going on at this time.


1. NIH ClinicalTrials.gov. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). Last updated January 2mri0, 2023. Accessed January 23, 2023. https://clinicaltrials.gov/ct2/show/NCT04720157

“This study is one of the most highly anticipated of all of the metastatic hormone-sensitive setting trials that we have going on at this time,” says Alicia Morgans, MD, MPH.

Trial explores 177Lu-PSMA-617 plus ADT and androgen receptor pathway inhibitor in mHSPC

,discusses trials exploring PSMA-targeted therapy at earlier disease stages and in combination regimens in patients with prostate cancer. Ravi is a medical oncologist at the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and an instructor in medicine at Harvard Medical School.

“There are a slew of ongoing trials looking at 177Lu-PSMA-617 in earlier stages of disease,” says Praful Ravi, MB, BChir, MRCP.

Dr. Ravi highlights ongoing trials of PSMA-targeted agents in prostate cancer

, discusses remaining needs and next steps with PSMA-targeted agents in prostate cancer.Ravi is a medical oncologisxt at the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and an instructor in medicine at Harvard Medical School.

“We have to remember that this is not a cure for prostate cancer…right now, it is another tool in the toolbox,” says Praful Ravi, MB, BChir, MRCP.

Dr. Ravi on unmet needs in PSMA-targeted paradigm

discusses the current state of targeted radionuclide therapies in the prostate cancer paradigm and previews what’s on the horizon for the burgeoning field of theranostics. Tagawa is a professor of clinical medicine and clinical urology and medical director of the Genitourinary Oncology Research Program at Weill Cornell Medicine in New York City. He is also an assistant attending physician on the Cornell campus at New York-Presbyterian Hospital

“In terms of both numbers of centers [administering radionuclides] as well as the amount of drug that’s available, [both] are going to increase over the next several months and certainly, year,” says Scott T. Tagawa, MD, MS, FACP. 

Insight for practicing clinicians on targeted radionuclide therapies for prostate cancer

discusses the pivotal VISION and TheraP trials that supported the FDA approval of 177Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting. Tagawa is a professor of clinical medicine and clinical urology and medical director of the Genitourinary Oncology Research Program at Weill Cornell Medicine in New York City. He is also an assistant attending physician on the Cornell campus at New York-Presbyterian Hospital.

177Lu-PSMA-617 is approved for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting.

Dr. Tagawa on pivotal trials supporting use of 177Lu-PSMA-617 in prostate cancer

discusses the next research steps with PSMA-targeted therapies in prostate cancer, including combining radionuclides with other agents and exploring novel approaches to targeting PSMA, such as antibodies. Tagawa is a professor of clinical medicine and clinical urology and medical director of the Genitourinary Oncology Research Program at Weill Cornell Medicine in New York City. He is also an assistant attending physician on the Cornell campus at New York-Presbyterian Hospital.

Emerging research includes combining radionuclides with other agents and exploring novel approaches to targeting PSMA, such as antibodies. 

Dr. Tagawa on next steps with PSMA-targeted therapies in prostate cancer

, recaps key findings from the phase 3 SPOTLIGHT trial data that were presented at the 2022 ASTRO Annual Meeting. He is currently a practicing urologist at Chesapeake Urology in Baltimore, Maryland.

"The idea that we may have reliable and consistently interpretable tests for these patients is exciting for the future," says Benjamin Lowentritt, MD, FACS.

Dr. Lowentritt discusses phase 3 SPOTLIGHT trial on new PSMA-PET tool

, Urology Associates, Nashville, TN, discusses how PSMA-PET imaging is revolutionizing prostate cancer care. “We all recognize it’s better than conventional imaging in terms of finding metastatic lesions and with that, it enables us to grow our potential patient based for targeted therapies.” says Morris.

“As the PSMA-PET market for access has grown, the coverage has actually been better than we anticipated when it first launched,” says David Morris, MD.

Dr. Morris on how PSMA-PET imaging has “exploded” in the past year

 discusses the value of PSMA-PET imaging in prostate cancer.  Goldfischer chaired a discussion on the rapidly emeging modalitiy during the 

 in Chicago, Illinois. Goldfischer is the director of the Research Department at Premier Medical Group in Poughkeepsie, New York, and new LUGPA president.

“PSMA scanning is definitely a game-changer with regard to imaging in advanced prostate cancer in urology,” says Evan R. Goldfischer, MD.

Next-Generation Imaging

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