Urinary Incontinence and Erectile Dysfunction After Robotic Versus Open Radical Prostatectomy: A Prospective, Controlled, Nonrandomised Trial.
Eva Haglind, Stefan Carlsson, Johan Stranne...
https://pubmed.ncbi.nlm.nih.gov/25770484Actively Recruiting
Phase Not Applicable
Age: 45Years +
MALE
ID06223295
Effectiveness of Focal Therapy Compared to Usual Care in Men With Intermediate-Risk Prostate Cancer
Led by Radboud University Medical Center · Updated on 2024-02-20
356
Participants Needed
5
Research Sites
78 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
I
Isala
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate focal therapy as a treatment option for men with intermediate-risk, unilateral clinically localized prostate cancer in the Netherlands. Traditional treatments like prostatectomy or radiotherapy often cause significant side effects such as incontinence and erectile dysfunction. Focal therapy targets only the cancerous part of the prostate, potentially reducing these side effects while maintaining cancer control. There is currently a lack of high-quality evidence supporting focal therapy, prompting this multi-center randomized controlled trial to assess its effectiveness, quality of life impact, and cost-effectiveness compared to usual care. Participants will be randomly assigned to receive either focal therapy using devices like TULSA, irreversible electroporation (IRE), or high-intensity focused ultrasound (HIFU), or usual care involving radical prostatectomy or radiotherapy. Focal therapy involves treating only the affected prostate area while preserving the rest, with follow-up including MRI scans at 12, 24, 36, 48, and 60 months, prostate biopsies when indicated, and PSA monitoring. Usual care follows standard radical treatment protocols with PSA and imaging follow-up according to guidelines. Throughout the study, participants will undergo regular assessments including PSA measurements, MRI scans, biopsies, and several quality of life questionnaires focusing on cancer-related, urinary, and sexual health outcomes. The main outcomes measured are treatment failure at 36 months and quality of life at 12 months. Secondary outcomes include metastasis-free survival, disease progression, mortality, adverse events, hospital stay, pathology results, and cost-effectiveness over 60 months. The trial includes intensive follow-up and safety monitoring, with a total participation timeline extending up to five years.
CONDITIONS
Brief Title
Effectiveness of Focal Therapy in Men With Prostate Cancer
Who Can Participate
Age: 45Years +
MALE
Eligibility Criteria
You may qualify if you...
- Men aged 45 years or older
- Gleason score of 7 (3+4 or 4+3; ISUP grade 2/3)
- PSA level of 20 ng/ml or less
- Clinical stage T2b disease or less
- Life expectancy of at least 10 years
- Prostate size of 5 cm or less in sagittal length and 6 cm or less in axial length
- Fit and eligible for radical surgery or radiotherapy
- No other active cancers
- No previous treatment of the prostate
- Sufficient understanding of Dutch language for trial information and questionnaires
You will not qualify if you...
- Unfit for general anesthesia or radical surgery
- Low volume low-risk prostate cancer (Gleason score 6 or less / ISUP grade 1)
- High-risk prostate cancer (Gleason score 8 or higher / ISUP grade above 3)
- Clinical T3 prostate cancer (extracapsular disease)
- Prior active therapy for prostate cancer
- Evidence of cancer spread outside the prostate
- Inability to tolerate transrectal ultrasound
- Presence of cardiac pacemaker
- Metal implants or stents in urethra or prostate
- ASA score of 4 or higher
- Prostatic calcifications or cysts interfering with effective focal therapy delivery
- Severe kidney impairment with glomerular filtration rate below 30 ml/min/1.73 m2
- Unable to give informed consent as judged by clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - One-time intervention
Participants receive either focal therapy, a one-time procedure to selectively treat part of the prostate, or usual care including radical prostatectomy or radiotherapy.
1 treatment visit (in-person)
Follow-up
Duration - Up to 60 months
Participants undergo intensive follow-up with PSA measurements quarterly and yearly prostate MRI scans, along with biopsies at 12 months and as needed based on MRI findings, to monitor treatment effectiveness and side effects.
Quarterly visits for PSA measurement and yearly visits for MRI; biopsy at 12 months and if indicated
Trial Site Locations
Total: 5 locations
1
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
2
Hifu kliniek
Etten-Leur, North Brabant, Netherlands
Not Yet Recruiting
3
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Not Yet Recruiting
4
Isala klinieken
Zwolle, Overijssel, Netherlands
Not Yet Recruiting
5
St. Antonius hospital
Nieuwegein, Utrecht, Netherlands
Not Yet Recruiting
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Research Team
L
Lauren te Molder
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years?
Jana S Hopstaken, Joyce G R Bomers, Michiel J P Sedelaar...
https://pubmed.ncbi.nlm.nih.gov/34489140Patients' and urologists' preferences for prostate cancer treatment: a discrete choice experiment.
E W de Bekker-Grob, M C J Bliemer, B Donkers...
https://pubmed.ncbi.nlm.nih.gov/23860533Evaluating the Trade-Offs Men with Localized Prostate Cancer Make between the Risks and Benefits of Treatments: The COMPARE Study.
Verity Watson, Neil McCartan, Nicolas Krucien...
https://pubmed.ncbi.nlm.nih.gov/31967521Oncological and Quality-of-life Outcomes Following Focal Irreversible Electroporation as Primary Treatment for Localised Prostate Cancer: A Biopsy-monitored Prospective Cohort.
Alexandar Blazevski, Matthijs J Scheltema, Brian Yuen...
https://pubmed.ncbi.nlm.nih.gov/31103721Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial.
Joseph L Chin, Michele Billia, James Relle...
https://pubmed.ncbi.nlm.nih.gov/26777228Twelve-month prostate volume reduction after MRI-guided transurethral ultrasound ablation of the prostate.
David Bonekamp, M B Wolf, M C Roethke...
https://pubmed.ncbi.nlm.nih.gov/29943185Evaluation of Focal Ablation of Magnetic Resonance Imaging Defined Prostate Cancer Using Magnetic Resonance Imaging Controlled Transurethral Ultrasound Therapy with Prostatectomy as the Reference Standard.
Elizabeth Ramsay, Charles Mougenot, Robert Staruch...
https://pubmed.ncbi.nlm.nih.gov/27545572Salvage Local Treatments After Focal Therapy for Prostate Cancer.
Giancarlo Marra, Massimo Valerio, Mark Emberton...
https://pubmed.ncbi.nlm.nih.gov/31412013Comparative Effectiveness Analyses of Salvage Prostatectomy and Salvage Radiotherapy Outcomes Following Focal or Whole-Gland Ablative Therapy (High-Intensity Focused Ultrasound, Cryotherapy or Electroporation) for Localised Prostate Cancer.
A Nathan, A Ng, A Mitra...
https://pubmed.ncbi.nlm.nih.gov/34740477