Jason M. Broderick

iTind showed continued efficacy and safety in patients with lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO), according to long-term data from the MT02 study presented during the 2022 AUA Annual Meeting.

The results, which came at a follow-up time of 50 to 79 months, demonstrated that the temporary implantable nitinol device sustained previously reported MT02 study outcomes, with iTind continuing to show a marked reduction in symptoms and improvement in quality of life and functional parameters.

“Overall IPSS and IPSS-QoL scores improved significantly for all groups vs baseline (

 <.0001),” Daniele Amparore, Division of Urology, Department of Oncology, University of Turin School of Medicine, Italy, said when reporting the findings at the AUA meeting.

“Only 4% of treatment failures occurred after 3-years’ follow-up,” added Amparore.

iTind offers patients an alternative to pharmaceutical management and surgery for alleviating LUTS related to BPO. It is an in-office procedure in which urologists place the device in a folded configuration in the prostatic urethra. During the next 5 to 7 days, the device expands before urologists completely remove it.

Overall, the MT02 study enrolled 81 patients with BPO-related LUTS at 9 global locations. At initial study baseline, these patients had IPSS of 10 or higher, Qmax (peak urinary flow) less than 12 ml/sec, and a prostate volume less than 75 ml. To avoid confounders, there was a mandatory wash-out period of 6 months for 5-ARIs and 1 month for alpha-blockers.

Three (Italy, Switzerland, and Belgium) of the 9 original sites agreed to continue the study beyond 36 months. Subsequently, there were 50 patients followed-up at these sites. For their analysis, the investigators divided the patients into 3 groups based on patients’ follow-up time: 50-59 months, 60-71 months, and 72-79 months.

Overall, data were available for 42 patients with 50 to 79 months of follow-up. Of the 42 patients, 24 had a follow-up time of 50 to 59 months, 13 had a follow-up time of 60 to 71 months, and 5 had a follow-up time of 72 to 79 months. There were 4 patients lost to follow-up, 2 patients who died of causes unrelated to iTind, and 2 patients with treatment failures (1 received TURP, and the other ThuLEP). Additional medication was not required for any patients in the study.

The change in average IPSS from baseline to follow-up was -8.88±8.96, -10.31±5.07, and -9.60±6.69, for the 50-59 months, 60-to-71 months, and 72-to-79 months groups, respectively. These numeric changes translated to percent changes of -41.0%, -54.6%, and -50.3%, respectively (

The change in average IPSS-QoL score was -2.04±1.81, -1.85±1.52, and -1.80±0.84, respectively. These numeric changes translated to percent changes of -46.8% (

Regarding safety, there were no patients who had late post-operative complications.

“The results of the study are excellent. The authors appropriately selected patients—those with small non-complicated prostates. So, the question now is, how will iTind work in more complicated larger prostates? I think that remains to be seen. And a lot of times when we appropriately select patients, we can get excellent results. But then when we go out in real clinical practice and start broadening the indications, we don't get the same results. So, I'm really excited to see how iTind does in clinical practice across the globe. But the initial results presented here are quite promising,” Amy Krambeck, MD, a professor of Urology, Department of Urology, Northwestern University, Feinberg School of Medicine, said in an interview with 

1. Amparore D, De Cillis S, Fiori C, et al. Long term follow-up of an international multicenter prospective study in application of temporary implantable nitinol device (iTind) in men with lower urinary tract symptoms for BPH. Presented during 2022 AUA Annual Meeting; New Orleans, LA. Abstract LBA01-06.

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Treatment with the temporary implantable nitinol device led to a marked reduction in symptoms and improvement in quality of life and functional parameters. 

iTind shows long-term efficacy for LUTS related to benign prostatic obstruction

Neoadjuvant axitinib (Inlyta) facilitated partial nephrectomy in patients with clear cell renal cell carcinoma (RCC) and complex masses with an imperative indication for nephron-sparing surgery but no viable pathway to receive the procedure, according to interim results from the phase 2 PADRES trial presented at the 2022 AUA annual meeting.

Explaining the background of the study, lead author Kevin Hakimi, a medical student at the UC San Diego School of Medicine, said, “Up to 25% of patients presenting with renal masses have renal insufficiency or other imperative indications for nephron-conserving management. Further, although partial nephrectomy is increasingly pursued in patients with large or complex masses, a subgroup of patients with imperative indication may not initially have masses that are amenable for partial nephrectomy.”

Accordingly, Hakimiet al launched the single-arm PADRES trial (NCT03438708) to determine whether neoadjuvant therapy with the TKI axitinib could cytoreduce renal tumors and enable patients with an imperative indication to receive a partial nephrectomy.

There were 26 patients enrolled in the study, with a median age of 69.5 years. Patients had biopsy-confirmed clear cell RCC strongly indicated for partial nephrectomy with the potential for dialysis dependence if given radical nephrectomy. All patients had complex renal masses, which the study defined as a RENAL Nephrometry score in the high range of 10 to 12 and a tumor stage of cT1b to cT3M0.

There were 14 males and 12 females. The ECOG performance status was 0 for nine patients, 1 for fifteen patients, and 2 for two patients.

Patients received oral axitinib at 5 mg twice daily for 8 weeks prior to nephrectomy. The primary end point of the trial was reduction in longest tumor diameter as determined by imaging criteria. Secondary outcome measures included tumor response per RESIST criteria, feasibility of partial nephrectomy, change in RENAL Nephrometry score, survival outcomes, and post-surgical complications.

At a median follow-up of 12 months, the median reduction in tumor size was 19% (

 <.001), with a median size of 7.7 cm prior to axitinib treatment and 6.3 cm after. Axitinib also led to a significant reduction in median RENAL Nephrometry score from 11 to 10 (

 <.001). There were 9 patients (34.6%) who had a partial response per RECIST criteria and the remaining 17 patients had stable disease.

The specific tumor staging pre- vs post-axitinib was as follows: T1a, 0 vs 5 patients, respectively; T1b, 4 vs 3 patients; T2a, 2 vs 0 patients; T3a, 17 patients each; T3b, 3 vs 1 patient.

“Twenty patients initially presented with T3a/T3b disease and 9 patients were downstaged,” said Hakimi.

Regarding the safety of pre-operative axitinib, Hakimi said that 5 patients experienced grade 3 adverse events related to the treatment, consisting of hypertension (n = 3), fatigue (n = 1), and weigh loss (n = 1).

Surgical outcomes showed that 25 patients were able to complete nephrectomy, comprising 19 partial nephrectomies and 6 radical nephrectomies. Twenty four (92.3%) of the patients had negative margins. There were 6 patients who had grade 3/4 post-operative complications.

Hakimi also noted that, importantly, “Patients who underwent partial nephrectomy had preserved renal function.”

Regarding next steps, he said the PADRES trial “continues to accrue with an end goal of 50 patients.”

1. Hakimi K, Campbell S, Nguyen M, et al. Interim analysis of PADRES (prior axitinib as a determinant of outcome of renal surgery nct03438708) clinical trial. Presented during 2022 AUA Annual Meeting; New Orleans, LA. Abstract LBA01-08.

Neoadjuvant axitinib facilitated partial nephrectomy in patients with an imperative indication for nephron-sparing surgery but no viable strategy to receive the procedure.

Neoadjuvant axitinib effective in subgroup of patients with renal cell carcinoma

The National Comprehensive Cancer Network (NCCN) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) guidelines now include the use of piflufolastat F 18 (Pylarify), along with all approved PSMA-PET imaging agents, for the selection of prostate cancer patients to receive PSMA-targeted radioligand therapy.

“We are pleased that the NCCN and SNMMI have now both updated their guidelines to include Pylarify, the most widely adopted PSMA PET imaging agent, for patient selection for PSMA-targeted lutetium radioligand therapy,” Bela Denes, MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a news release. “We believe this will increase the accessibility to PSMA-targeted therapeutics for patients with advanced disease and further validates the benefit and utility that Pylarify provides to the US prostate cancer community.”

The FDA approved the PSMA-PET imaging agent piflufolastat F18 (previously also known as 18F-DCFPyL and PyL) in 2021 for identifying suspected metastasis or recurrence of prostate cancer.

 The approval was supported in large part by findings from the phase 3 CONDOR trial, in which 63.9% of men with biochemically recurrent prostate cancer who had no evidence of disease on standard-of-care imaging had a change in intended management after their 18F-DCFPyL–PET/CT scan.

The multicenter phase study enrolled men with rising PSA after definitive therapy and negative or equivocal standard-of-care imaging. Patients were required to have a PSA level ≥0.2 if they had undergone radical prostatectomy or a PSA level ≥2.0 if they were treated with radiation therapy or cryotherapy.

The primary end point was correct localization rate (CLR), defined as percentage of patients with a 1:1 correspondence between at least 1 lesion identified by PyL–PET/CT and the composite standard of truth (pathology, correlative imaging, or PSA response). PyL scans were read by 3 blinded independent central readers.

Overall, there were 208 evaluable patients, about 85% of whom underwent RP, either alone or with radiation. Median PSA level of the cohort was 0.8 ng/mL, and 68.8% had a PSA level <2.0 ng/mL. Some 27.9% had received at least 1 prior systemic therapy.

Detection of disease as manifested by a positive 18F-DCFPyL–PET/CT scan was 65.9%, 59.6%, and 59.1% by the 3 readers.

The prespecified criterion for CLR success was for the lower limit of the 95% CI to exceed 20% for at least 2 of the 3 readers. For every reader, the lower bound of the 95% CI for the CLR was well in excess of the 20% benchmark, meeting the primary end point of the study.

The CLRs were 85.6% (95% CI, 78.8%-92.3%), 87.0% (95% CI, 80.4%-93.6%), and 84.8% (95% CI, 77.8%-91.9%) by the 3 readers. Some 64% of the evaluable patients had a change in intended management due to the scan.

1.Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. Published online May 11, 2022. Accessed May 11, 2022. https://bit.ly/37AfuHO.

2. Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. Published online May 27, 2021. Accessed May 27, 2021. https://bwnews.pr/3vtMgBh.

3. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase 3, multicenter study [published online before print February 26, 2021.] doi: 10.1158/1078-0432.CCR-20-4573

The guidelines now include the use of piflufolastat F 18, along with all approved PSMA-PET imaging agents, for the selection of prostate cancer patients to receive PSMA-targeted radioligand therapy.

NCCN, SNMMI add piflufolastat F18 to guidelines for prostate cancer imaging

The IsoPSA test has been added to the National Comprehensive Cancer Network Prostate Cancer guidelines for early detection of the disease, according to Cleveland Diagnostics, the developer of the assay.

The blood-based, non-invasive IsoPSA test is used prior to an initial biopsy to assess the likelihood that a patient has high-grade prostate cancer.

“IsoPSA is intended to be used in men over 50 who are being screened for prostate cancer as a way of helping to decide whether or not a biopsy should be done. So the standard paradigm is someone has a PSA test, and we know that PSA is only a little better than a coin flip in determining whether or not someone has prostate cancer. In our prior published studies, IsoPSA is far better than that. It has 80% accuracy or better in predicting for hi-grade cancer. And in fact, if it's used in conjunction with MRI, we found that it was close to 85% accurate. So it's far better than PSA in deciding whether or not someone might have a hi-grade cancer that deserves a biopsy,” Eric Klein, MD, fellow, Stanford University Distinguished Careers Institute and Emeritus Professor and Chair, Glickman Urological and Kidney Institute, Cleveland Clinic, said in an interview earlier this year with 

Klein was the lead investigator on a real-world clinical validation study of IsoPSA that was published in the 

The study included a diverse group of 38 community-based and academic sites withing the Cleveland Clinic health system. There were 900 patients under evaluation for prostate cancer who were enrolled at these locations. Of these, 734 met the study inclusion criteria, which comprised age ≥50 years, total serum PSA ≥4 ng/ml and <100 ng/ml, and no history of prostate cancer. The study investigators assessed biopsy recommendations of participating clinicians before and after receipt of IsoPSA results.

The results showed that in men with total PSA ≥4 ng/ml, IsoPSA led to a 55% (284 vs 638) net reduction in prostate biopsy recommendations. Further, there was also a 9% reduction in MRI imaging recommendations.

“What we found was really remarkable and it was what we had hoped for. The whole point of using IsoPSA is because it has improved sensitivity and specificity for finding higher grade cancers—grade seven or higher. The intended use of IsoPSA is to reduce the number of biopsies that show only benign tissue or show only low-grade cancer; those are things that we'd rather not find on labs,” said Klein.

“And what we found was that incorporating IsoPSA into practice for these 38 providers changed their recommendations about whether additional evaluation was necessary based on an initial total PSA; More than half—55%—of biopsies that otherwise would have been recommended, and probably would have happened, actually were recommended against. And so in this population of 900 patients, we saved a little more than half of them from the need for undergoing a biopsy with high confidence that we're not overlooking a hi-grade cancer,” Klein added.

Regarding the next steps with IsoPSA, Klein said, “Going forward we have a paper pending on a multinational, multicenter trial of little over 1000 men that confirmed the prior performance characteristics of IsoPSA in terms of sensitivity and specificity of positive and negative predictive value and that sort of thing; that's under review currently. And IsoPSA received FDA breakthrough technology designation about 2 years ago and so there is a pending FDA application for premarket approval.”

1. Scovell JM, Hettel D, Abouassaly R, et al. IsoPSA® Reduces Provider Recommendations for Biopsy and Magnetic Resonance Imaging in Men with Total Prostate Specific Antigen ≥4 ng/ml: A Real-World Observational Clinical Utility Study. 

 2022;9(2):173-180. doi: 10.1097/UPJ.0000000000000291