{"product_id":"focal-therapy-for-prostate-cancer-a-patient-friendly-guide-to-the-latest-clinical-trials","title":"Focal Therapy for Prostate Cancer: A Patient-Friendly Guide to the Latest Clinical Trials","description":"\u003ch1\u003eFocal Therapy for Prostate Cancer: A Patient-Friendly Guide to the Latest Clinical Trials\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: A New Direction in Prostate Cancer Care\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#study-methods\"\u003eHow This Review Was Conducted\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#key-findings\"\u003eKey Findings: A Detailed Look at Ongoing Clinical Trials\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#clinical-implications\"\u003eWhat This Means for Patients: Clinical Implications\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#limitations\"\u003eUnderstanding the Limitations\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#recommendations\"\u003eActionable Recommendations 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\u003eFocal therapy destroys only the cancerous lesion in the prostate, sparing healthy tissue.\u003c\/li\u003e\n\u003cli\u003eCurrent guidelines do not endorse focal therapy for standard use outside clinical trials.\u003c\/li\u003e\n\u003cli\u003eLarge trials like CHRONOS are comparing focal therapy to radical treatments for cancer control and quality of life.\u003c\/li\u003e\n\u003cli\u003eFocal therapy requires precise tumor identification using advanced imaging like mpMRI.\u003c\/li\u003e\n\u003cli\u003eLong-term data on cancer control and survival for focal therapy are still maturing.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"introduction\"\u003eIntroduction: A New Direction in Prostate Cancer Care\u003c\/h2\u003e\n\u003cp\u003eIf you've been diagnosed with localized prostate cancer (cancer that hasn't spread beyond the prostate), you are likely considering your treatment options. For decades, the main choices have been active surveillance (closely monitoring the cancer), radical prostatectomy (surgical removal of the entire prostate), or radical radiation therapy (targeting the whole prostate with external beams or radioactive seeds). While effective, surgery and full-prostate radiation carry significant risks of side effects, including long-term urinary incontinence (involuntary urine leakage) and erectile dysfunction (difficulty achieving or maintaining an erection).\u003c\/p\u003e\n\u003cp\u003eThis has led researchers to explore a middle ground: \u003cstrong\u003efocal therapy\u003c\/strong\u003e. Focal therapy is defined as the guided destruction of only the image-defined, biopsy-confirmed cancerous lesion along with a small safety margin of surrounding tissue. It primarily uses advanced imaging like multiparametric magnetic resonance imaging (mpMRI), a special type of MRI scan that provides detailed pictures of the prostate, to precisely target the tumor. The goal is to achieve cancer control similar to radical treatments while dramatically reducing the impact on a patient's quality of life.\u003c\/p\u003e\n\u003cp\u003eA variety of energy-based focal therapy modalities now exist, each using a different method to destroy cancer cells:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eHigh-Intensity Focused Ultrasound (HIFU):\u003c\/strong\u003e Uses concentrated ultrasound waves to heat and destroy tissue.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCryoablation (Cryotherapy):\u003c\/strong\u003e Uses extremely cold gas to freeze and kill cancer cells.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIrreversible Electroporation (IRE):\u003c\/strong\u003e Uses short, high-voltage electrical pulses to permanently create holes in cancer cell membranes, causing cell death.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFocal Laser Ablation (FLA):\u003c\/strong\u003e Uses laser energy delivered through a thin fiber to heat and destroy the tumor.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTransurethral Ultrasound Ablation (TULSA):\u003c\/strong\u003e Uses ultrasound energy delivered from a device inserted through the urethra to heat and ablate prostate tissue.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWater Vapor Ablation (Rezum®):\u003c\/strong\u003e Uses injected steam to destroy targeted tissue.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eDespite promising results over the last 10-15 years, current guidelines from the American Urological Association (AUA) and the National Comprehensive Cancer Network (NCCN) do not yet endorse focal therapy for standard use outside of clinical trials. Furthermore, the U.S. Food and Drug Administration (FDA) does not approve focal therapy specifically for cancer treatment, classifying it only as a tissue-destructive procedure.\u003c\/p\u003e\n\u003cp\u003eThe drive to research these options is reinforced by major long-term studies on traditional treatments. The PROTECT trial, which followed 1,643 men for a median of 15 years, found no significant difference in prostate cancer-specific death among men who chose active monitoring, surgery, or radiation. While radical treatments reduced cancer progression and spread, this did not translate to a survival advantage for most men, and they came with more side effects. Similarly, the PIVOT trial, with 731 men followed for 12.7 years, found no difference in mortality between surgery and active surveillance, but surgery led to more incontinence and erectile dysfunction. These findings underscore why the medical community is actively seeking effective treatments with fewer life-altering consequences.\u003c\/p\u003e\n\n\u003ch2 id=\"study-methods\"\u003eHow This Review Was Conducted\u003c\/h2\u003e\n\u003cp\u003eTo provide a clear picture of the current research landscape, the authors of this review performed an exhaustive search of two major databases up to December 1st, 2023: ClinicalTrials.gov (a registry of clinical studies) and PubMed (a database of biomedical literature).\u003c\/p\u003e\n\u003cp\u003eThey used a wide range of search terms related to prostate cancer and every major type of focal therapy, including \"high-intensity focused ultrasound (HIFU),\" \"cryoablation,\" \"irreversible electroporation (IRE),\" and \"focal laser ablation.\" The focus was on identifying feasibility trials, Phase 2, and Phase 3 clinical trials published from 2015 onward or currently ongoing. The selection process was conducted by two authors, with the entire team reaching a consensus on which trials to include. This narrative review is intended to give patients and clinicians a snapshot of the dynamic and evolving field of focal therapy research.\u003c\/p\u003e\n\n\u003ch2 id=\"key-findings\"\u003eKey Findings: A Detailed Look at Ongoing Clinical Trials\u003c\/h2\u003e\n\u003cp\u003eThe review identified numerous clinical trials at various stages: some are actively recruiting, some have finished recruiting but are analyzing results, and others have recently published findings. These trials investigate all the major focal therapy modalities, focusing on both cancer control (oncological outcomes) and patient quality of life. Importantly, several novel trials are studying the added benefit of combining focal therapy with hormonal treatments like androgen deprivation therapy (ADT). Below is a detailed breakdown of the key trials organized by their primary focus.\u003c\/p\u003e\n\n\u003ch3\u003eTrials Comparing Multiple Energy Modalities\u003c\/h3\u003e\n\u003cp\u003e\u003cstrong\u003eThe CHRONOS Trial (NCT04049747):\u003c\/strong\u003e This is a large, ambitious prospective study in the UK consisting of two parallel randomized controlled trials (RCTs). An RCT is a study where participants are randomly assigned to different treatment groups, which is the gold standard for comparing treatments.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eCHRONOS-A\u003c\/strong\u003e is a non-inferiority trial. It aims to recruit 1,190 men to test whether focal therapy alone (using either HIFU or cryotherapy) is \u003cstrong\u003enot worse than\u003c\/strong\u003e radical therapy (surgery, radiation, or brachytherapy) in terms of 5-year progression-free survival (PFS). PFS is defined as the time until the cancer progresses, requires salvage treatment, spreads, or causes death.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCHRONOS-B\u003c\/strong\u003e is a multi-arm trial aiming to recruit 1,260 men. It will investigate whether adding neoadjuvant (pre-treatment) drugs like finasteride or bicalutamide to focal therapy improves 5-year failure-free survival compared to focal therapy alone.\u003c\/li\u003e\n\u003cli\u003eBoth CHRONOS trials will also closely monitor side effects, quality of life, and economic costs.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eThe ATLANTA Trial (NCT03763253):\u003c\/strong\u003e This is a unique phase 2 RCT in England for men with metastatic prostate cancer (cancer that has spread). It aims to recruit 399 patients by January 2027 to test if treating the primary prostate tumor with either \u003cstrong\u003efocal therapy (HIFU\/cryo) or radical therapy (surgery\/radiation)\u003c\/strong\u003e in addition to standard drug treatments for metastases improves outcomes compared to drug treatments alone. Primary outcomes include biopsy results at 6 months and progression-free survival at 2-4 years.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eUniversity of Cincinnati Trial (NCT05790213):\u003c\/strong\u003e This is a phase 2, single-arm study exploring a combination approach for intermediate-risk cancer. It plans to enroll 57 patients to receive focal therapy plus a 6-month course of ADT and a novel hormone drug called Apalutamide. The main goal is to see the proportion of men with no significant cancer in treated and untreated areas at the 6-month biopsy.\u003c\/p\u003e\n\n\u003ch3\u003eTrials Focused on High-Intensity Focused Ultrasound (HIFU)\u003c\/h3\u003e\n\u003cp\u003e\u003cstrong\u003eThe PART Trial (ISRCTN99760303):\u003c\/strong\u003e This was a completed feasibility study in the UK that successfully randomized 82 men with intermediate-risk cancer to either surgery (41 men) or HIFU (41 men). While not designed to prove which was better, it confirmed that a large RCT was possible and found that, in the short-to-medium term, men treated with HIFU reported better health-related quality of life scores. This trial paved the way for larger studies like CHRONOS.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe HIFUSA Trial (NCT03531099):\u003c\/strong\u003e This is an ongoing phase 3 RCT in France directly comparing HIFU to active surveillance in men with low-risk prostate cancer. The primary goal is to see how many men in the active surveillance group convert to needing radical treatment within 48 months compared to the HIFU group.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe FOCALE Trial (NCT03568188):\u003c\/strong\u003e This single-arm study in Belgium is assessing the success of HIFU specifically for intermediate-risk cancer. The primary endpoint is the percentage of positive biopsies in the treated area of the prostate at 12 months post-treatment.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe ENHANCE Trial (NCT03845751):\u003c\/strong\u003e This is a small, single-arm phase 2 trial in France testing HIFU combined with a short course of ADT for intermediate-risk cancer. It will measure treatment failure via biopsy at 12 months in 20 patients.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe EMERHIT Trial (NCT05710861):\u003c\/strong\u003e This is a French randomized medical economics trial comparing focal HIFU to total prostatectomy. Its main goal is to evaluate the cost-utility ratio—essentially, the cost per quality-adjusted life year (QALY)—of HIFU compared to surgery at 24 months.\u003c\/p\u003e\n\n\u003ch3\u003eTrials on Other Focal Therapy Modalities\u003c\/h3\u003e\n\u003cp\u003e\u003cstrong\u003eCAPTAIN Trial for TULSA (NCT05027477):\u003c\/strong\u003e This RCT is comparing TULSA-Pro® therapy to radical prostatectomy. It has dual primary endpoints: efficacy (freedom from treatment failure at 36 months) and safety (preservation of urinary continence and erectile function at 12 months).\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePRIS Trials for IRE (NCT05513443):\u003c\/strong\u003e These are two planned RCTs. PRIS 1 will compare IRE to radical prostatectomy, with urinary continence at 12 months as the primary goal. PRIS 2 will compare IRE to radiation therapy, focusing on irritative urinary symptoms at 12 months.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePRESERVE Trial for IRE (NCT04972097):\u003c\/strong\u003e This single-arm study is evaluating both the efficacy (negative biopsy at 12 months) and safety of IRE treatment.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eFocal Laser Ablation (FLA) Trials:\u003c\/strong\u003e Several single-arm trials are investigating FLA, including one at Mayo Clinic (NCT02600156) and others in San Diego (NCT05826470) and by Avenda Health (NCT06047509). These primarily focus on safety and short-to-medium-term success rates.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eVAPOR 2 Trial for Water Vapor Ablation (NCT05683691):\u003c\/strong\u003e This single-arm trial is evaluating the freedom from disease progression or salvage therapy at 36 months, along with urinary incontinence rates at 12 months.\u003c\/p\u003e\n\n\u003ch2 id=\"clinical-implications\"\u003eWhat This Means for Patients: Clinical Implications\u003c\/h2\u003e\n\u003cp\u003eThe sheer volume and design of these trials signal a major shift in prostate cancer research. The medical community is actively investing time and resources to determine if focal therapy can reliably become a standard treatment option. The implications are significant:\u003c\/p\u003e\n\u003cp\u003eFirst, there is a clear recognition that for many men with localized disease, \u003cstrong\u003epreserving quality of life is as important as treating the cancer\u003c\/strong\u003e. Large trials like CHRONOS are directly comparing the quality-of-life outcomes of focal therapy against radical treatments, which is a critical patient-centered focus.\u003c\/p\u003e\n\u003cp\u003eSecond, research is becoming more nuanced. Instead of just asking \"Is focal therapy effective?\", trials are now asking more specific questions: \"Is it as good as surgery for certain men?\" (CHRONOS-A), \"Can we make it better by adding drugs?\" (CHRONOS-B, Cincinnati trial), and \"Is it a good option for men with more advanced disease?\" (ATLANTA trial). This reflects a move toward personalized medicine.\u003c\/p\u003e\n\u003cp\u003eFinally, the variety of energy modalities being tested means that if focal therapy is validated, there may be multiple technical options available. Different energies might be better suited for tumors in different locations or of different sizes, allowing urologists to tailor the treatment to the individual's specific cancer anatomy.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eUnderstanding the Limitations\u003c\/h2\u003e\n\u003cp\u003eWhile the research is promising, it is crucial to understand the current limitations. The most important limitation is that \u003cstrong\u003efocal therapy remains an investigational treatment\u003c\/strong\u003e according to major U.S. and international guidelines. This is because the long-term data (10-15 years) on cancer control and survival is still maturing.\u003c\/p\u003e\n\u003cp\u003eMany of the most definitive trials, like CHRONOS, will not have results for several years. The trials mentioned often have primary endpoints at 1, 2, or 5 years, but prostate cancer is often slow-growing, and long-term follow-up is essential to ensure cancer does not recur in untreated parts of the gland.\u003c\/p\u003e\n\u003cp\u003eAdditionally, focal therapy requires precise tumor identification. Its success is heavily dependent on high-quality mpMRI and accurate targeted biopsies to map the cancer's exact location and extent. Not all cancers are suitable for focal therapy; it is generally considered for men with a single, clearly defined tumor or significant cancer confined to one area of the prostate.\u003c\/p\u003e\n\n\u003ch2 id=\"recommendations\"\u003eActionable Recommendations for Patients\u003c\/h2\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eDiscuss All Options:\u003c\/strong\u003e If diagnosed with localized prostate cancer, have a detailed conversation with your urologist about all management strategies, including active surveillance, radical therapies, and the possibility of participating in a clinical trial for focal therapy.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAsk About Trial Eligibility:\u003c\/strong\u003e If you are interested in focal therapy, ask your doctor if you might be a candidate for any ongoing clinical trials in your area. You can also search for trials yourself on ClinicalTrials.gov.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUnderstand the \"Why\":\u003c\/strong\u003e If considering focal therapy, understand the specific rationale for your case. Ask: What is the exact location and size of my tumor? What modality is being recommended and why? What are the short-term and potential long-term risks?\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSeek a Multidisciplinary Opinion:\u003c\/strong\u003e Prostate cancer care often benefits from a multidisciplinary team. Consider getting opinions from both a urologist who specializes in focal therapy and a radiation oncologist to compare all modern treatment paths, including advanced radiation techniques which also aim to reduce side effects.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFocus on Quality of Life Metrics:\u003c\/strong\u003e When reviewing trial results or discussing outcomes with your doctor, pay close attention to quality of life data—specifically rates of pad-free urinary continence and erectile function preservation—in addition to cancer control rates.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat is focal therapy for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eFocal therapy is a treatment that destroys only the cancerous lesion in the prostate, guided by advanced imaging like multiparametric MRI. It uses energy sources such as high-intensity focused ultrasound (HIFU), cryoablation, or laser to target the tumor while sparing surrounding healthy tissue. The goal is to achieve cancer control similar to radical treatments but with fewer side effects.\u003c\/p\u003e\n\u003ch3\u003eIs focal therapy approved for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eNo, focal therapy is not yet approved by the FDA for cancer treatment; it is classified only as a tissue-destructive procedure. Major guidelines from the American Urological Association and the National Comprehensive Cancer Network do not endorse it for standard use outside of clinical trials. This is because long-term data on cancer control and survival are still being collected.\u003c\/p\u003e\n\u003ch3\u003eWhat are the side effects of focal therapy compared to surgery?\u003c\/h3\u003e\n\u003cp\u003eFocal therapy aims to reduce side effects like urinary incontinence and erectile dysfunction that are common with radical prostatectomy. The article notes that trials like the PART study found men treated with HIFU reported better health-related quality of life scores in the short-to-medium term compared to surgery. However, long-term side effect data are still being gathered.\u003c\/p\u003e\n\u003ch3\u003eWhy does prostate cancer come back after focal therapy?\u003c\/h3\u003e\n\u003cp\u003eFocal therapy treats only the visible tumor, so cancer may recur in untreated areas of the prostate. Its success depends on precise tumor mapping with mpMRI and targeted biopsies. The article emphasizes that long-term follow-up is essential because prostate cancer is often slow-growing, and recurrence in untreated parts of the gland is a concern.\u003c\/p\u003e\n\u003ch3\u003eWho is eligible for focal therapy for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eFocal therapy is generally considered for men with a single, clearly defined tumor or significant cancer confined to one area of the prostate. It requires precise tumor identification using high-quality mpMRI and targeted biopsies. Not all cancers are suitable, and it is not yet a standard treatment outside clinical trials.\u003c\/p\u003e\n\u003ch3\u003eHow long do focal therapy clinical trials follow patients?\u003c\/h3\u003e\n\u003cp\u003eMany focal therapy trials have primary endpoints at 1, 2, or 5 years, but long-term follow-up is essential because prostate cancer is often slow-growing. The most definitive trials, like CHRONOS, will not have results for several years, and long-term data on cancer control and survival is still maturing.\u003c\/p\u003e\n\u003ch3\u003eWhat are the risks of focal therapy for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eFocal therapy aims to reduce side effects compared to radical treatments, but it carries risks. The success depends on precise tumor identification, and there is a possibility of cancer recurrence in untreated parts of the prostate. Long-term data on cancer control is still maturing, so risks are not fully known.\u003c\/p\u003e\n\u003ch3\u003eShould I get a second opinion before choosing focal therapy for prostate cancer?\u003c\/h3\u003e\n\u003cp\u003eA second opinion is valuable because focal therapy is not yet a standard treatment; major guidelines do not endorse it outside clinical trials, and long-term cancer control data are still maturing. A specialist can confirm your tumor is suitable—requiring precise mpMRI and targeted biopsy—and discuss whether a clinical trial fits your case. Since trials compare focal therapy with radical treatments and active surveillance, an independent expert can help weigh options. 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\n\u003cstrong\u003eOriginal Article Title:\u003c\/strong\u003e A narrative clinical trials review in the realm of focal therapy for localized prostate cancer\u003cbr\u003e\n\u003cstrong\u003eAuthors:\u003c\/strong\u003e Alon Lazarovich, Vijay Viswanath, Aaron S. Dahmen, Abhinav Sidana\u003cbr\u003e\n\u003cstrong\u003ePublication:\u003c\/strong\u003e \u003cem\u003eTranslational Cancer Research\u003c\/em\u003e, Vol 13, No 11, November 2024\u003cbr\u003e\n\u003cstrong\u003eDOI:\u003c\/strong\u003e 10.21037\/tcr-23-2406\u003cbr\u003e\n\u003cem\u003eThis patient-friendly article is based on peer-reviewed research and aims to comprehensively translate the original scientific content for an educated patient audience, preserving all key data, trial details, and clinical context.\u003c\/em\u003e\n\u003c\/p\u003e","brand":"Diagnostic Detectives Network","offers":[{"title":"Default Title","offer_id":45698732228764,"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-focal-therapy-for-prostate-cancer-a-patient-friendly-guide-to-the-latest-clinical-trials-hero.png?v=1784499084","url":"https:\/\/diagnosticdetectives.com\/es\/products\/focal-therapy-for-prostate-cancer-a-patient-friendly-guide-to-the-latest-clinical-trials","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}