Focal laser ablation (FLA) for the focal treatment of localized prostate cancer

Not Applicable

Recruiting

Conditions: C61
Malignant neoplasm of prostate

Registration Number: DRKS00025500

Lead Sponsor: Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 10

Inclusion Criteria

1. Voluntary written consent after verbal explanation for FLA
2. Men aged 18–80 years with a life expectancy of at least 10 years
3. PSA = 15ng / ml
4. Clinically localized prostate cancer
5. Correspondence of suspicious mpMRI areas (PI-RADS score 3-5) with areas of positive punches
6. Gleason score = 3 + 4 = 7a, ISUP category 1 or 2
7. Maximum size of the lesion visible on MRI 20mm
8. A maximum of 1 histologically confirmed carcinoma focus
9. Normal anal and rectal anatomy
10. Minimum distance of the carcinoma to the rectum 8mm
11. General anesthesia possible for patient (ASA status 1-2)

Exclusion Criteria

1. Clinical tumor stage not locally limited
2. Imaging evidence of lymph node metastases, extracapsular spread or distant metastasis
3. More than one histologically proven carcinoma focus
4. Punch biopsy carcinoma detection without MR correlate in the same sector
5. MRI lesions PI-RADS 3-5 that have not been clarified by a targeted biopsy
6. Existing urethral stenosis
7. Unresolved coagulation disorders
8. Untreated urogenital infections
9. Contraindication to magnetic resonance imaging
10. Participation in a therapy study on the prostate within the last 30 days
11. Lack of consent
12. Ongoing anti-hormonal therapy
13. Other oncological pretreatments of the prostate such as radiation or HIFU of the same area
14. Anti-androgen / androgen withdrawal therapy within the last 6 months
15. Ongoing other oncological therapy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioptic tumor freedom of the treated areas (infield) as part of an MRT / TRUS random + target fusion biopsy after 6 months

Secondary Outcome Measures

Name	Time	Method
Biopsy tumor freedom outside the treated areas as part of the control random biopsy or targeted biopsies in the mpMRI of newly emerged foci (outfield)<br><br>Functional outcome:<br>• Continence:<br>o Changes in the ICS-male SF score<br>• micturition:<br>o Changes in the IPSS score<br>• Potency:<br>o Changes in the IIEF 5 score<br><br>Life quality:<br>• Changes in the EORTC QLQ 30 (version 3.0)<br><br>Anxiety and psychological stress:<br>• Change in HADS (Hospital Anxiety and Depression Scale)<br><br>Security:<br>• The occurrence of all treatment-related side effects during and after treatment according to Clavien-Dindo and CTCAE version 5.0