Clinical Trials Logo

Clinical Trial Summary

PSA (Prostate-specific antigen) testing has significantly increased the number of men diagnosed with prostate cancer (PCa) and especially patients with low and intermediate risk disease. The effect of radical treatment (treatment of the entire prostate gland) in these risk groups is disputable while the risk of adverse effects, with erectile dysfunction and urinary incontinence, is not. Active surveillance (AS) has been developed as an alternative to radical treatment with the aim of avoiding or delaying radical treatment by closely monitoring for signs of tumor progression. Active surveillance is regarded as the treatment of choice for low-risk prostate cancer. Focal therapy may have a crucial role in improving active surveillance protocols for patients with intermediate localized prostate cancer. Focal eradication of the index-tumor may delay or avoid indefinitely radical treatment for this patient group while significantly reducing treatment-related side effects. Improved MRI-diagnostics and MRI/ ultrasound fusion technology have optimized tumor mapping and classification and this in turn has made partial treatment of the prostate a feasible treatment option. This study is a prospective cohort study. Patients with intermediate (high-risk) localized PCa and a visible index tumor will be treated with high-intensity focused ultrasound (HIFU). The aim of the study is to show that there is a significant effect of focal treatment on surveillance biopsies and a reduced conversion to radical treatment, without compromising survival outcomes compared to historical controls (retrospective cohort). A cohort from the more than 450 patients included in the local AS-protocol with MRI at Vestfold hospital trust since 2009 will serve as controls.


Clinical Trial Description

1 Needs description It is unclear if eradication with focal treatment of the index-tumor of patients with intermediate-risk prostate cancer followed by active surveillance can reduce the need for radical, whole-gland treatment of the prostate and thereby treatment side effects. It is important for urologists and patients to know if focal treatment of prostate cancer is both a safe and effective treatment option. If proven so, focal treatment of prostate cancer can be offered as a viable, intermediate treatment option for a large group of patients who currently only have the choice between either surveillance or radical treatment. Thus, there is an unmet need to document the outcome of focal treatment in selected patients with prostate cancer, both in terms of efficacy and safety 2. Hypotheses, aims and objectives 2.1 Hypothesis: Focal treatment of biopsy-verified, localized, MRI-visible, intermediate-risk (and high-risk fo elderly patients) prostate cancer is a safe and effective treatment option. Side effects following focal treatment are transient and mild compared to established and well-documented radical treatment options. 2.2 Aims of the study: To investigate if focal treatment of localized prostate cancer followed by MRI-supplemented active surveillance conveys sufficient tumor control to enable patients to continue indefinitely in this follow-up protocol without the need to convert to radical treatment, with none or mild side effects and without compromising oncological outcomes. 2.3 Objectives: Primary objectives: - Eradication of the signal tumor (<20% positive biopsies in the treated area after one year) - Low conversion rates to radical treatment (<20%) - Good long-term oncological results (<5% metastasis and <1% prostate cancer deaths at 10 years) - Good functional results (<10% of patients with long-term side effects on erectile function and continence) Secondary objectives: - Evaluation of the ability of MRI to predict biopsy results during follow-up. - Health-related quality of life 3. Methodology This study is a prospective, single-arm, case-control cohort study with consecutive patients with intermediate-risk, MRI-visible prostate cancer treated focally with HIFU. Participants will be compared to historical controls (patients observed with AS at SiV 2009-2017). The study design follows the international multidisciplinary consensus on trial design for focal therapy in PCa (28, 29). Patients will primarily be recruited from Vestfold-Telemark County but recruitment from other institutions in Norway is encouraged. More formal referral arrangements will be sought with Aleris (Oslo), Telemark Hospital Trust and Vestre Viken Hospital Trust. 3.1 Project arrangements, method selection and analyses From a scientific and methodological point of view a randomized, parallel-group study would have been preferable with patients receiving either AS+ (HIFU) or simple AS follow-up. However, experience from several investigative centers have shown that randomization is difficult to carry out in practice. This is because patients are aware of the HIFU possibility, and, if randomized to standard treatment, often refuse participation and demand HIFU treatment. This problem would likely be exacerbated in this study, where the control group would be offered only follow-up while study arm patients receive tumor-directed treatment with presumed few side-effects. Furthermore, the investigators have learned from own historic controls that AS is "good medicine" for merely half of the patients with intermediate-risk prostate cancer after 5 years. Since it is difficult, based on today's diagnostic tools, to identify patients that will not progress significantly over time, some form of tumor-directed treatment for all patients is sensible. Finally, patients in the historical control group were diagnosed and risk-classified by the same parameters and diagnostic tools that are currently in use. Follow-up of these patients was also very similar to the one outlined for the study patients. The investigators are not aware of any significant change in clinical practice that would suggest that the historical controls at the study institution are not representative of current patients with intermediate risk profile. Patients who are interested in focal treatment of prostate cancer are aware of the radical treatment alternatives but are skeptical of the side effects. These patients want to know their risk of progression (metastasis and death), the risk of having to undergo radical treatment at a later stage and the short-term and long-term side effects if they choose focal treatment. We believe that this study will provide these answers for a representative Norwegian patient population. Based on these considerations, the investigators believe that the best and most ethical design is the one proposed here, where all eligible patients receive the same treatment and are then compared to a historical control group. Study population and Power-estimate Approximately half of active surveillance patients (50%) experience progression of their disease during 5-10 years follow-up (9). This correlates with the outcome of historical AS patients at the study institution. The investigators estimate that only 20% of the newly diagnosed AS patients receiving HIFU will experience a progression of their disease after 10 years. In order to detect such a reduction in progression rate, the trial will need to include 194 patients. With 20% expected dropouts, the number of patients needed to include in the HIFU cohort will be 245. The sample size calculations are based on the ClinCalc program (http://clincalc.com/stats/samplesize.aspx). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04549688
Study type Interventional
Source The Hospital of Vestfold
Contact Sven Löffeler, MD, PhD
Phone +47-33342000
Email sven.loffeler@siv.no
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date September 2030

See also
  Status Clinical Trial Phase
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A