EvaluatioN of High-Intensity Focused Ultrasound (HIFU) Hemi-ablation and short-term AndrogeN deprivation therapy Combination to Enhance prostate control for intermediate risk localized prostate cancer: the ENHANCE prospective feasibility trial

Conditions

Intermediate risk prostate cancer

Brief summary

Proportion of treatment failure 12 months after HIFU treatment, identified as men harbouring clinically significant prostate cancer in treated and/or untreated areas of the prostate

Detailed description

Biological results: serum PSA and testosterone levels at 1, 3, 6 and 12 months post-treatment, Erectile function : IIEF-5 score changes at differrent time ponts post-treatment, as comared to baseline, proportion of men cho are potent at baseline and then sustain erectile dysfunction, Ejaculatory function: MSHQ-EjD score changes at different time points post-treatment as compared to baseline, Continence at 1, 3, 6 and 12 months post-treatment as compared to baseline : changes of ICSmaleIS score, at differrent time points post-treatment; proportion of continent men, Voiding function at 1, 3, 6 and 12 months post-treatment: changes of IPSS score at different time points post-treatment as compared to baseline, Quality of life at 1, 3, 6 and 12 months post-treatment: changes of the EQ-5D-5L score at different time points post-treatment, Complications / treatment-related toxicity, Secondary intervention : proportion of men requiring salvage secondary prostate cancer intervention due to treatment failure

Related papers

No related papers found yet.

Interventions

DRUGELIGARD 22

DRUG5 mg

DRUGpoudre et solvant pour solution injectable

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of treatment failure 12 months after HIFU treatment, identified as men harbouring clinically significant prostate cancer in treated and/or untreated areas of the prostate	—

Secondary

Measure	Time frame
Biological results: serum PSA and testosterone levels at 1, 3, 6 and 12 months post-treatment, Erectile function : IIEF-5 score changes at differrent time ponts post-treatment, as comared to baseline, proportion of men cho are potent at baseline and then sustain erectile dysfunction, Ejaculatory function: MSHQ-EjD score changes at different time points post-treatment as compared to baseline, Continence at 1, 3, 6 and 12 months post-treatment as compared to baseline : changes of ICSmaleIS score, at differrent time points post-treatment; proportion of continent men, Voiding function at 1, 3, 6 and 12 months post-treatment: changes of IPSS score at different time points post-treatment as compared to baseline, Quality of life at 1, 3, 6 and 12 months post-treatment: changes of the EQ-5D-5L score at different time points post-treatment, Complications / treatment-related toxicity, Secondary intervention : proportion of men requiring salvage secondary prostate cancer intervention due to trea	—

Measure

Time frame

Biological results: serum PSA and testosterone levels at 1, 3, 6 and 12 months post-treatment, Erectile function : IIEF-5 score changes at differrent time ponts post-treatment, as comared to baseline, proportion of men cho are potent at baseline and then sustain erectile dysfunction, Ejaculatory function: MSHQ-EjD score changes at different time points post-treatment as compared to baseline, Continence at 1, 3, 6 and 12 months post-treatment as compared to baseline : changes of ICSmaleIS score, at differrent time points post-treatment; proportion of continent men, Voiding function at 1, 3, 6 and 12 months post-treatment: changes of IPSS score at different time points post-treatment as compared to baseline, Quality of life at 1, 3, 6 and 12 months post-treatment: changes of the EQ-5D-5L score at different time points post-treatment, Complications / treatment-related toxicity, Secondary intervention : proportion of men requiring salvage secondary prostate cancer intervention due to trea

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Countries

France

Outcome results

None listed