{"product_id":"targeted-ultrasound-therapy-for-prostate-cancer-a-2-year-study-on-safety-and-effectiveness","title":"Targeted Ultrasound Therapy for Prostate Cancer: A 2-Year Study on Safety and Effectiveness","description":"\u003ch1\u003eTargeted Ultrasound Therapy for Prostate Cancer: A 2-Year Study on Safety and Effectiveness\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n    \u003cli\u003e\u003ca href=\"#introduction\"\u003eIntroduction: Why This Research Matters\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#who-was-studied\"\u003eWho Was Studied and How?\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#the-treatment\"\u003eThe Treatment: How MRI-Guided Focal HIFU Works\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#key-findings\"\u003eKey Findings: Cancer Control and Treatment Failure\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#side-effects-safety\"\u003eSide Effects and Safety\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#psa-results\"\u003ePSA Level Results\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#quality-of-life\"\u003eQuality of Life and Functional Outcomes\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#study-limitations\"\u003eUnderstanding the Study's Limitations\u003c\/a\u003e\u003c\/li\u003e\n    \u003cli\u003e\u003ca href=\"#clinical-implications\"\u003eWhat This Means for Patients\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eFailure-free survival at 24 months was 94.1%, with only 3 of 51 men needing salvage radiotherapy.\u003c\/li\u003e\n\u003cli\u003eOf 31 men who had follow-up biopsy, 83.9% had no detectable cancer after treatment.\u003c\/li\u003e\n\u003cli\u003eThe most common side effect was temporary urinary retention (21.6%); severe complications were rare.\u003c\/li\u003e\n\u003cli\u003eErectile function recovered to near-baseline levels by 24 months, and overall quality of life remained stable.\u003c\/li\u003e\n\u003cli\u003ePSA levels dropped by 69.3% at 3 months and stabilized, indicating effective destruction of treated cancer.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"introduction\"\u003eIntroduction: Why This Research Matters\u003c\/h2\u003e\n\u003cp\u003eProstate cancer is one of the most common cancers in men. For decades, the standard curative treatments have been radical prostatectomy (surgical removal of the entire prostate) or radiotherapy (radiation to the whole prostate). While these are effective, they often come with significant side effects, including long-term difficulties with urination, urinary incontinence (leakage), and erectile dysfunction.\u003c\/p\u003e\n\u003cp\u003eThis has led to a search for treatments that can cure the cancer while better preserving the organ and a man's quality of life. Focal therapy is one such approach. Instead of treating the entire prostate, focal therapy aims to destroy only the area containing the significant tumor, leaving the healthy surrounding tissue untouched.\u003c\/p\u003e\n\u003cp\u003eHigh-Intensity Focused Ultrasound (HIFU) is a leading focal therapy technology. It uses a precisely aimed beam of ultrasound energy to heat and destroy cancer cells in a specific spot. This study was designed to see how feasible, safe, and effective MRI-guided focal HIFU is for men with low- and intermediate-risk prostate cancer over a two-year period.\u003c\/p\u003e\n\n\u003ch2 id=\"who-was-studied\"\u003eWho Was Studied and How?\u003c\/h2\u003e\n\u003cp\u003eThis was a prospective study, meaning patients were enrolled and followed forward in time according to a specific plan. It was conducted at three hospitals in Austria from 2021 to 2024. Importantly, this was a single-arm, feasibility trial. This means all participants received the HIFU treatment, and there was no comparison group receiving surgery or radiation. The main goals were to check if the treatment was practical to perform and to monitor early results on cancer control and side effects.\u003c\/p\u003e\n\u003cp\u003eThe study included 52 men, but one was excluded because his PSA level was too high at the start, leaving 51 men in the final analysis. To be eligible, patients had to have:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eNewly diagnosed, non-metastatic prostate cancer.\u003c\/li\u003e\n    \u003cli\u003eLow- or intermediate-risk disease (using the D'Amico classification system).\u003c\/li\u003e\n    \u003cli\u003eA PSA level at or below 15 ng\/mL.\u003c\/li\u003e\n    \u003cli\u003eA tumor stage of T2b or less (meaning the cancer was confined to the prostate).\u003c\/li\u003e\n    \u003cli\u003eAn MRI scan showing a suspicious lesion that was confirmed by a targeted biopsy.\u003c\/li\u003e\n    \u003cli\u003eNo significant cancer suspected on the opposite side of the prostate.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eAll patients were fully informed about standard options (surgery, radiation, active surveillance) and chose not to pursue active surveillance. The median age of participants was 67 years, and the median PSA level before treatment was 7.55 ng\/mL.\u003c\/p\u003e\n\n\u003ch2 id=\"the-treatment\"\u003eThe Treatment: How MRI-Guided Focal HIFU Works\u003c\/h2\u003e\n\u003cp\u003eThe treatment used a device called the Focal One system. Before the procedure, doctors used MRI scans to precisely map the prostate and the tumor location. This planning was done in collaboration between urologists and radiologists.\u003c\/p\u003e\n\u003cp\u003eDuring the treatment, which was done under general anesthesia:\u003c\/p\u003e\n\u003col\u003e\n    \u003cli\u003eA probe was inserted into the rectum.\u003c\/li\u003e\n    \u003cli\u003eUsing live ultrasound for guidance, the HIFU energy was focused only on the biopsy-confirmed tumor area. A safety margin of 9 mm (about a third of an inch) of tissue around the tumor was also treated.\u003c\/li\u003e\n    \u003cli\u003eIn some cases, a contrast agent was used during the procedure to check if the ablation was complete; if any area looked untreated, an extra pass of HIFU was applied.\u003c\/li\u003e\n    \u003cli\u003eThe procedure had a median time of 85 minutes, and the median volume of prostate tissue treated was 12 mL.\u003c\/li\u003e\n    \u003cli\u003eA Foley catheter (urinary catheter) was placed at the end and typically remained for a median of 5 days.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003cp\u003eThe neurovascular bundles (critical for erectile function) and the urethra were not specifically spared during this treatment, as the priority was completely treating the targeted area.\u003c\/p\u003e\n\n\u003ch2 id=\"key-findings\"\u003eKey Findings: Cancer Control and Treatment Failure\u003c\/h2\u003e\n\u003cp\u003eThe researchers tracked a primary outcome called \u003cstrong\u003eFailure-Free Survival (FFS)\u003c\/strong\u003e. This was defined as being free from needing salvage whole-gland therapy (surgery or radiation), systemic therapy, developing metastases, or dying from prostate cancer.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eAt the 24-month mark, the Failure-Free Survival rate was 94.1%.\u003c\/strong\u003e This means that 48 out of the 51 men (94.1%) did not require radical salvage treatment within two years. Only 3 patients (5.9%) needed salvage radiotherapy.\u003c\/p\u003e\n\u003cp\u003eA crucial measure of success is whether cancer is still present after treatment. The protocol recommended a follow-up biopsy at 12 months.\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e31 out of 51 patients (60.1%) underwent at least one biopsy after HIFU.\u003c\/li\u003e\n    \u003cli\u003eOf these 31 men, \u003cstrong\u003e26 had no detectable cancer on their biopsy, a success rate of 83.9%.\u003c\/strong\u003e\n\u003c\/li\u003e\n    \u003cli\u003eCancer was found in 5 men: three had low-grade (ISUP 1) cancer, one had intermediate-grade (ISUP 2), and one had high-grade (ISUP 4) cancer.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe three men who needed salvage treatment had different situations: one developed a high-grade cancer on the opposite side of the prostate, one had a low-grade cancer on the opposite side but his PSA kept rising, and one had intermediate-grade cancer in the original treatment area. No patients developed metastases or died from prostate cancer during the study.\u003c\/p\u003e\n\n\u003ch2 id=\"side-effects-safety\"\u003eSide Effects and Safety\u003c\/h2\u003e\n\u003cp\u003eThe safety profile was closely monitored. A total of 14 patients (27%) experienced at least one adverse event related to the treatment.\u003c\/p\u003e\n\u003cp\u003eThe most common issue was \u003cstrong\u003etransient acute urinary retention\u003c\/strong\u003e (inability to urinate), which occurred in 11 men (21.6%). This was typically managed with a catheter for a short period.\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e5 men (10%) needed a standard transurethral catheter.\u003c\/li\u003e\n    \u003cli\u003e6 men (12%) required a suprapubic catheter (placed through the abdomen into the bladder) under local anesthesia.\u003c\/li\u003e\n    \u003cli\u003e2 men (4%) later needed a procedure called a TURP (transurethral resection of the prostate) to relieve obstruction.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eOther side effects included:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eUrinary tract infections in 3 patients (6%).\u003c\/li\u003e\n    \u003cli\u003eEpididymitis (inflammation of a structure near the testicle) in 2 patients (4%).\u003c\/li\u003e\n    \u003cli\u003eOnly one new case of Grade 2 urinary incontinence (leakage during physical activity) was reported, and this was linked to a complicated infection in a patient with diabetes.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eImportantly, there were no severe (Clavien-Dindo Grade 4 or 5) complications directly related to the HIFU procedure.\u003c\/strong\u003e Two patients died during follow-up from unrelated cardiovascular events (a heart attack and a heart valve rupture). One patient was diagnosed with bladder cancer 19 months after HIFU, but doctors considered this unlikely to be caused by the treatment.\u003c\/p\u003e\n\n\u003ch2 id=\"psa-results\"\u003ePSA Level Results\u003c\/h2\u003e\n\u003cp\u003ePSA (Prostate-Specific Antigen) levels are tracked after prostate cancer treatment to monitor for recurrence.\u003c\/p\u003e\n\u003cp\u003eIn this study, PSA levels dropped sharply immediately after treatment:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eBaseline mean PSA: 7.55 ng\/mL\u003c\/li\u003e\n    \u003cli\u003eAt 3 months post-HIFU: 2.31 ng\/mL\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThis represents a \u003cstrong\u003e69.3% reduction in PSA levels\u003c\/strong\u003e. After this initial drop, PSA levels stabilized and remained in a low range for the rest of the study. At 24 months, the mean PSA was 2.7 ng\/mL. This pattern of a sharp decline and then stabilization is a positive sign that the treated cancer cells were effectively destroyed.\u003c\/p\u003e\n\u003cp\u003eThe PSA response was consistent across patients with different initial cancer grades (ISUP 1, 2, and 3), with all groups maintaining low PSA levels over two years.\u003c\/p\u003e\n\n\u003ch2 id=\"quality-of-life\"\u003eQuality of Life and Functional Outcomes\u003c\/h2\u003e\n\u003cp\u003ePreserving quality of life is a major goal of focal therapy. This study measured several key areas:\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eUrinary Symptoms (IPSS):\u003c\/strong\u003e The International Prostate Symptom Score measures urinary difficulties. Interestingly, outcomes depended on a patient's symptoms before treatment.\n    \u003c\/p\u003e\u003cul\u003e\n        \u003cli\u003eMen who started with \u003cstrong\u003egood urinary function maintained it\u003c\/strong\u003e throughout the two years.\u003c\/li\u003e\n        \u003cli\u003eMen who started with \u003cstrong\u003emoderate to severe symptoms saw significant improvement\u003c\/strong\u003e. Their average symptom score improved by 7.8 points (a 59% reduction) by 24 months, meaning their bothersome urination problems got much better.\u003c\/li\u003e\n    \u003c\/ul\u003e\n\n\u003cp\u003e\u003cstrong\u003eErectile Function (IIEF-5):\u003c\/strong\u003e Erectile function, measured by a questionnaire, showed a predictable pattern.\n    \u003c\/p\u003e\u003cul\u003e\n        \u003cli\u003eScores dropped slightly at the 3-month checkup (mean 14.9 vs. baseline 18.2).\u003c\/li\u003e\n        \u003cli\u003eHowever, they largely recovered by 6-12 months and had returned to near-baseline levels by 24 months (mean 18.8). This indicates that any impact on erectile function was mostly temporary.\u003c\/li\u003e\n    \u003c\/ul\u003e\n\n\u003cp\u003e\u003cstrong\u003eOverall Quality of Life (SF-36):\u003c\/strong\u003e Patients completed a comprehensive quality-of-life survey. Scores across all domains—including physical function, mental health, and pain—remained stable from baseline through the 12- and 24-month checkups. This is a strong indicator that the treatment did not negatively impact patients' overall well-being.\u003c\/p\u003e\n\n\u003ch2 id=\"study-limitations\"\u003eUnderstanding the Study's Limitations\u003c\/h2\u003e\n\u003cp\u003eWhile the results are encouraging, it's important to understand the study's limitations, as the authors openly acknowledge:\u003c\/p\u003e\n\u003col\u003e\n    \u003cli\u003e\n\u003cstrong\u003eShort Follow-up:\u003c\/strong\u003e Two years is too short to know about long-term cancer control or very late side effects. Some cancers can recur many years later.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eNo Comparison Group:\u003c\/strong\u003e Because everyone got HIFU, we can't directly say it's better or as good as surgery or radiation. Larger trials comparing these treatments head-to-head are needed.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eSmall Number of Patients:\u003c\/strong\u003e With 51 patients, the study gives a good early signal but isn't large enough to provide definitive proof of effectiveness.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eNot Everyone Had a Biopsy:\u003c\/strong\u003e Only 31 of the 51 men (61%) had the recommended 12-month biopsy. This means some cases of residual cancer might have been missed, potentially making the success rate look slightly better than it is.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eCOVID-19 Impact:\u003c\/strong\u003e The pandemic caused some scheduling delays, meaning some tests weren't done exactly on the planned dates.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eImperfect MRI:\u003c\/strong\u003e MRI scans are very good but not perfect at finding all prostate cancer. Some \"MRI-invisible\" cancers might have been missed before treatment or during follow-up.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003ch2 id=\"clinical-implications\"\u003eWhat This Means for Patients\u003c\/h2\u003e\n\u003cp\u003eThis study adds promising data to the growing evidence for focal HIFU as a treatment option for select men with localized prostate cancer. For patients, the key takeaways are:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003e\n\u003cstrong\u003eFocal HIFU appears to be a feasible and safe treatment\u003c\/strong\u003e that can effectively target the cancer area in the short term, with 94.1% of men avoiding more radical treatment for at least two years.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eSide effects are mostly mild and temporary.\u003c\/strong\u003e The most common issue, temporary urinary retention, is manageable. Significant long-term incontinence was rare (one case in this study), and erectile function showed good recovery.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003eQuality of life is preserved.\u003c\/strong\u003e Patients did not see a decline in their overall health-related quality of life, and many with urinary symptoms actually saw improvement.\u003c\/li\u003e\n    \u003cli\u003e\n\u003cstrong\u003ePatient selection is critical.\u003c\/strong\u003e This treatment is currently best suited for men with low- or intermediate-risk cancer that is clearly visible on MRI and confirmed by biopsy, with no signs of significant cancer elsewhere in the prostate.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe authors conclude that these positive early results support moving forward with larger, randomized controlled trials that compare focal HIFU directly to standard whole-gland treatments over a longer period (5-10 years). For now, as noted in guidelines, focal therapy like HIFU should ideally be performed within clinical trials or well-regulated settings where outcomes are carefully tracked.\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eHow effective is focal HIFU for prostate cancer in the short term?\u003c\/h3\u003e\n\u003cp\u003eIn a 2-year study of 51 men with low- or intermediate-risk prostate cancer, focal HIFU achieved a failure-free survival rate of 94.1%, meaning only 3 men required salvage radiotherapy. Among those who had a follow-up biopsy, 83.9% had no detectable cancer. No patients developed metastases or died from prostate cancer during the study.\u003c\/p\u003e\n\u003ch3\u003eWhat are the side effects of focal HIFU for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eThe most common side effect was temporary urinary retention, occurring in 21.6% of patients, typically managed with a catheter. Urinary tract infections occurred in 6% and epididymitis in 4%. Only one new case of grade 2 urinary incontinence was reported, linked to a complicated infection. No severe complications directly related to the HIFU procedure occurred.\u003c\/p\u003e\n\u003ch3\u003eDoes focal HIFU affect erectile function and quality of life?\u003c\/h3\u003e\n\u003cp\u003eErectile function scores dropped slightly at 3 months but largely recovered by 6-12 months and returned to near-baseline levels by 24 months. Overall quality of life, measured by the SF-36 survey, remained stable across all domains from baseline through 24 months. Men with moderate to severe urinary symptoms before treatment saw significant improvement.\u003c\/p\u003e\n\u003ch3\u003eWhy might prostate cancer come back after focal HIFU treatment?\u003c\/h3\u003e\n\u003cp\u003eIn the study, residual or new cancer was found in 5 of 31 men who had follow-up biopsies. Three men required salvage radiotherapy due to high-grade cancer on the opposite side, rising PSA, or intermediate-grade cancer in the treated area. Limitations include short follow-up, small sample size, and that not all men had a biopsy, which may miss some residual cancer.\u003c\/p\u003e\n\u003ch3\u003eWho is eligible for focal HIFU treatment for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eFocal HIFU is for men with newly diagnosed, non-metastatic prostate cancer that is low- or intermediate-risk. Eligibility requires a PSA level of 15 ng\/mL or lower, tumor stage T2b or less, and an MRI-visible lesion confirmed by biopsy. No significant cancer should be suspected on the opposite side of the prostate.\u003c\/p\u003e\n\u003ch3\u003eWhat happens during MRI-guided focal HIFU treatment?\u003c\/h3\u003e\n\u003cp\u003eThe procedure is done under general anesthesia. A probe is inserted into the rectum, and using live ultrasound guidance, HIFU energy is focused only on the biopsy-confirmed tumor area plus a 9 mm safety margin. A contrast agent may be used to check completeness, and a urinary catheter is placed afterward, typically for about 5 days.\u003c\/p\u003e\n\u003ch3\u003eHow long does it take to recover from focal HIFU treatment?\u003c\/h3\u003e\n\u003cp\u003eMost men recover within a few weeks. A urinary catheter is usually needed for about 5 days. Temporary urinary retention is common, affecting about 1 in 5 men, and is managed with a catheter. Erectile function may dip at 3 months but typically returns to near-baseline by 24 months. Overall quality of life remains stable.\u003c\/p\u003e\n\u003ch3\u003eShould I get a second opinion before choosing focal HIFU for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eA second opinion can help confirm that focal HIFU is appropriate for your specific case. This study focused on men with low- or intermediate-risk prostate cancer, a PSA of 15 ng\/mL or lower, and a tumor visible on MRI with no significant cancer on the opposite side. If your situation differs, other treatments might be more suitable. A second opinion can also review your MRI and biopsy to ensure the cancer is accurately characterized. Diagnostic Detectives Network provides independent expert second opinions.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eOriginal Article Title:\u003c\/strong\u003e \"Focal Therapy Using High-Intensity Focused Ultrasound for Low- and Intermediate-Risk Prostate Cancer: Results from a Prospective, Multicenter Feasibility Trial\"\u003cbr\u003e\n\u003cstrong\u003eAuthors:\u003c\/strong\u003e Gabor Rosta, Simon Turba, Dong-Ho Mun, Azad Shehab, Leon Saciri, Paul F. Engelhardt, Patricia Weisz, Claus Riedl, Ghazal Ameli, Stephan Doblhammer, and Harun Fajkovic\u003cbr\u003e\n\u003cstrong\u003ePublished in:\u003c\/strong\u003e \u003cem\u003eCancers\u003c\/em\u003e 2025, 17, 3429.\u003cbr\u003e\n\u003cstrong\u003eNote:\u003c\/strong\u003e This patient-friendly article is based on peer-reviewed research and aims to accurately translate the study's findings, methods, and conclusions for an educated patient audience.\u003c\/p\u003e","brand":"Diagnostic Detectives Network","offers":[{"title":"Default Title","offer_id":45698259288220,"sku":null,"price":0.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0599\/5449\/5644\/files\/ddn-medical-article-targeted-ultrasound-therapy-for-prostate-cancer-a-2-year-study-on-safety-and-effectiveness-hero.png?v=1784499284","url":"https:\/\/diagnosticdetectives.com\/ar\/products\/targeted-ultrasound-therapy-for-prostate-cancer-a-2-year-study-on-safety-and-effectiveness","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}