Multi-center MRI-guided focal laser ablation of prostate cancer.

Multi-center MRI-guided focal laser ablation of prostate cancer. - MRI-guided focal laser ablation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44447

Enrollment

Registered

2018-08-14

Start date

2018-10-24

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant adenocarcinoma of the prostate Prostate cancer

Interventions

Patients will receive MRI and robot-guided focal laser ablation as main prostate cancer treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging) 2. maximum MRI visible lesion size is

Exclusion criteria

Exclusion criteria: 1. history of prostate surgery 2. history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis 3. history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer) 4. severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18 5. tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles 6. maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI 7. Impossibility to obtain a valid informed consent 8. Patients unable to undergo MR imaging, including those with contra-indications 9. Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection) 10. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging 11. Patients with evidence for nodal or metastatic disease 12. Patients with an estimated Glomerular Filtration Ratio (eGFR)

Design outcomes

Primary

Measure	Time frame
The oncologic safety (PSA measurements at 6 weeks, 3, 6, 12 and 24 months; MR imaging at 6, 12 and 24 months; and*targeted and random systematic 12-core biopsy at 12 months post focal therapy), functional outcome, complication rates (i.e. urinary incontinence, irritative/obstructive bowel and erectile dysfunction), re-treatment percentage, the EORTC QLQ-PR25 scale for sexual symptoms, ICIQ (incontinence), IPSS (urinary problems) and SHIM IIEF-5 (erectile dysfunctioning), success rate, complication rates (according to Clavien system for surgical complications), operating time and hospital stay.	—

Measure

Time frame

The oncologic safety (PSA measurements at 6 weeks, 3, 6, 12 and 24 months; MR imaging at 6, 12 and 24 months; and*targeted and random systematic 12-core biopsy at 12 months post focal therapy), functional outcome, complication rates (i.e. urinary incontinence, irritative/obstructive bowel and erectile dysfunction), re-treatment percentage, the EORTC QLQ-PR25 scale for sexual symptoms, ICIQ (incontinence), IPSS (urinary problems) and SHIM IIEF-5 (erectile dysfunctioning), success rate, complication rates (according to Clavien system for surgical complications), operating time and hospital stay.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)