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

Prostate Cancer Clinical Trial

— TEPSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744494
• Other study ID #: 15/0424
• Status: Completed
• Phase: N/A
• Start date: March 2, 2016
• Est. completion date: February 26, 2018

Study information

• Verified date: May 2023
• Source: University College Hospital, Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 26, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Orchiectomy
• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life

Intervention

Procedure:
• Bilateral simple orchidectomy (BSO)

• Bilateral Subcapsular Orchidectomy

• Bilateral Epididymal-sparing Orchidectomy

Locations

Country	Name	City	State
Nigeria	University College Hospital	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital, Ibadan

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

Chibuzo INC, Takure AO, Shittu OB, Okeke LI,

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socioeconomic standing of the patients	The EPIC 2.2002 questionnaire was used to determine the relationship, occupational, educational and financial statuses of the patients	Snap-shot assessment at enrolment
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)

External Links

•   Article publication on simple and pseudotesticular techniques of orchidectomy