Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer

Study Overview
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Brief Summary
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The therapeutic efficacy of three types of orchidectomy was ascertained as well as the QoL and scrotal cosmetic satisfaction of patients in the three surgical arms. Two of these surgeries produced a pseudotesticle (BSCO, BESO) while one (BSO) did not.

Detailed Description
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Patients with prostate cancer (PCa) were grouped into three surgical arms: BSO (bilateral simple orchidectomy), BSCO (bilateral subcapsular orchidectomy) and BESO (bilateral epididymal-sparing orchidectomy). Preoperatively, baseline serum testosterone, PSA, Quality of life (QoL) and pre-operative testicular volumes were obtained. Timed interval sampling for serum testosterone and PSA variation was done post-operatively. By three months post-op, the cosmetic appeal of the scrotal appearance, post-operative pseudotesticular volumes and QoL were also assessed. The therapeutic efficacy of the surgeries was determined by the rates of decline of serum testosterone and PSA, as well as the nadirs achieved. The variations in the pre-and post-operative QoL was analysed.

Official Title
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Comparison of the Therapeutic Efficacy and Patient Satisfaction of Three Techniques of Bilateral Orchidectomy in Prostate Cancer Patients of a Nigerian Sub-population (TEPSO)

Conditions
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Prostate Cancer, Quality of Life, Orchiectomy

Intervention / Treatment
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* Procedure: Bilateral simple orchidectomy (BSO)
* Procedure: Bilateral Subcapsular Orchidectomy
* Procedure: Bilateral Epididymal-sparing Orchidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy Exclusion Criteria: Patients who have had bilateral orchidectomy Those who opt for medical castration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups of patients subjected to a type of orchidectomy each
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral simple orchidectomy (BSO)<br>The patients would have the testis, epididymis and distal cord structures excised | Procedure: Bilateral simple orchidectomy (BSO)<br> <br> |
| Experimental: Subcapsular orchidectomy (BSCO)<br>The tunica albuginea was incised longitudinally and the testicular parenchyma scraped off it. The hilar region was secured with a haemostat and the parenchyma excised off it. A haemostatic suture was applied at the hilum. A running interlocking water-tight capsular suture was inserted | Procedure: Bilateral Subcapsular Orchidectomy<br> <br> |
| Experimental: Epididymal-sparing orchidectomy (BESO)<br>The epididymal sinus was developed. The epididymal vessels were sequentially clamped and divided, removing the testicle from the epididymis. The caput was looped to meet the head and the adjoining surfaces of the body sutured together (epididymoplasty) Vasectomy done to reduce future risk of epididymitis | Procedure: Bilateral Epididymal-sparing Orchidectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summative and domain quality of life scores | Expanded Prostate Cancer Index Composite- 26 questionnaires were also used to assess various aspects of the QoL pre-and post-operatively. EPIC 26 scores are ranked from 0 to 100 with higher scores indicating better function and less bother. Urinary incontinence, Lower Urinary Tract Symptoms, Bowel function/bother, Sexual function/bother, Hormone and vitality were assessed. | Three months | 
| Summative and domain quality of life scores | Life Satisfaction -8 questionnaire was used to complement the EPIC-26 in the QoLassessment pre-and post-operatively. Lisat-8 is ranked from 1 to 6, with 5 and 6 denoting satisfaction (5: Satisfying; 6: Satisfying) while scores of 4 and below connote varied degrees of dissatisfaction (1: very dissatisfying; 2: Dissatisfying; 3: Rather dissatisfying; 4: Rather satisfying) EPIC 26 scores are ranked from 0 to 100 with higher scores indicating better function and less bother. Urinary incontinence, Lower Urinary Tract Symptoms, Bowel function/bother, Sexual function/bother, Hormone and vitality were assessed. | Three months | 
| Change in pseudotesticular volume | A Prader orchidometer was used to measure the pre-operative testicular volume and post-operative pseudotesticular volume in cm3 | Three months | 
| Satisfaction with scrotal appearance | Patient rating of cosmetic appeal of the scrotum using a graduated Visual Analog Scale rated between 0 and 100 to signify a score of 0 to 100%. Higher values indicated better satisfaction with scrotal appearance | three months after the orchidectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PSA levels | The serum PSA levels in ng/ml were measured pre-operatively, at removal of the testes, hourly for the first three hours, at seven days and three months post-operatively. Percentage PSA declines, PSA nadirs (ng/ml) and time to the attainment of PSA nadirs (hours) were determined from the data obtained. | Three months (timed interval sampling) | 
| Serum testosterone levels | The serum testosterone levels in nmol/l were measured pre-operatively, at removal of the testes, hourly for the first three hours, at seven days and three months post-operatively. The attainment of surgical castrate levels of 20nmol/l or medical castrate levels of 20 nmol/l or medical castrate levels of 50nmol/l was assessed for as well as the testosterone nadirs achieved (nmol/l) and time to the attainment of testosterone nadirs (hours). | Three months (timed interval sampling) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orchidectomy, pseudotesticle