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2022-502067-38-00Active, not recruitingPhase 1

Neoadjuvant ADT with TULSA

Effect of neoadjuvant Degarelix on MRI-guided transurethral ultrasound ablation in patients with intermediate-risk prostate cancer: A pilot study

Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 May 2023

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Brief summary (registry, in English)

The first part of the study, the pre-TULSA ADT period, aims to investigate the impact of short-term ADT using degarelix on prostate and tumor characteristics on MRI, and the second part, the post-TULSA period, the synergistic impact of combining neoadjuvant degarelix with whole-gland TULSA on treatment and clinical outcomes.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
15 (estimated)
First submitted
30 Nov 2022
Start date
29 Jun 2023
Lead sponsor
Turku University Central Hospital
EU CT number
2022-502067-38-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 15
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior Pca treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen synthesis inhibitors
  • Hip replacement surgery or other metal in the pelvic area

Other illness

  • Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug (e.g., glucagon, buscopan)
  • Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist
  • Severe, active cardiovascular comorbidity including unstable angina pectoris, congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardial infarction within the last six months
  • Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.
  • Evidence of extraprostatic disease based on imaging (MRI, bone scintigraphy, single-photon emission tomography, computed tomography, prostate-specific membrane antigen-positron emission tomography [PSMA-PET]) or histopatholog
  • History of chronic inflammatory conditions (e.g., inflammatory bowel disease) affecting the rectum (also includes rectal fistula and anal/rectal stenosis)

Age

  • Secondary malignancy unless disease-free survival is > 8 years

Other

  • Relative or absolute contraindication to degarelix
  • Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumo
  • Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumo

Who the study is looking for

  • Male age ≥ 40 years, candidate for radical Pca treatment
  • Informed consent: The patient must speak Finnish, English, or Swedish and must be able to understand the meaning of the study. The patient must be willing and able to sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.
  • Estimated life expectancy > 8 years
  • At least one MRI-visible and biopsy-concordant tumor defined as Prostate Imaging–Reporting and Data System v2 (PI-RADS v2.1) ≥3
  • Biopsy-confirmed, intermediate-risk localized Pca: Clinical or radiological stage ≤ T2c, N0, M0, ISUP GG 2 or 3, Biopsy obtained ≥ 6 weeks and ≤ 12 months before treatment
  • PSA ≤ 20 ng/ml
  • No prior definitive treatment of Pca
  • Eligible for MRI
  • Eligible for general anesthesia (American Society of Anesthesiologists Class III or less
  • Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use is discontinued 12 months before and throughout the study period

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Turku University HospitalTurkuFinlandActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.