Clinical trial NCT03744494: Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Quality of Life
Orchiectomy
Keywords: orchidectomy
pseudotesticle
Lead sponsor: University College Hospital, Ibadan
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of patients subjected to a type of orchidectomy each
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Summative and domain quality of life scores
timeFrame: Three months
measure: Summative and domain quality of life scores
timeFrame: Three months
measure: Change in pseudotesticular volume
timeFrame: Three months
measure: Satisfaction with scrotal appearance
timeFrame: three months after the orchidectomy
Secondary outcomes:
measure: Serum PSA levels
timeFrame: Three months (timed interval sampling)
measure: Serum testosterone levels
timeFrame: Three months (timed interval sampling)
Other outcomes:
measure: Socioeconomic standing of the patients
timeFrame: Snap-shot assessment at enrolment
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital
state: Oyo
Study officials:
affiliation: University College Hospital, Ibadan
name: Ijeoma NC Chibuzo, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chibuzo INC, Takure AO, Shittu OB, Okeke LI,
citation: Chibuzo INC, Takure AO, Shittu OB, Okeke LI. Cosmetic Appeal, HRQoL, and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer. Prostate Cancer. 2021 Nov 26;2021:9968570. doi: 10.1155/2021/9968570. eCollection 2021.