Prostate CancerTEPSONCT03744494
Cosmetic Appeal, HRQoL and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer
A study testing Bilateral simple orchidectomy (BSO), Bilateral Subcapsular Orchidectomy and Bilateral Epididymal-sparing Orchidectomy in people with Prostate Cancer and Quality of Life, run by University College Hospital, Ibadan at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Quality of Life, Orchiectomy
- What is being tested?
- Bilateral simple orchidectomy (BSO), Bilateral Subcapsular Orchidectomy and Bilateral Epididymal-sparing Orchidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteNigeria
- Study dates
- 2 Mar 2016to 26 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy
Who cannot join
- Patients who have had bilateral orchidectomy
- Those who opt for medical castration
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer, Quality of Life, Orchiectomy
- Being tested
- Bilateral simple orchidectomy (BSO), Bilateral Subcapsular Orchidectomy, Bilateral Epididymal-sparing Orchidectomy
- Keywords
- orchidectomy, pseudotesticle
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral simple orchidectomy (BSO)Procedure or surgery
Bilateral Subcapsular OrchidectomyProcedure or surgery
Bilateral Epididymal-sparing OrchidectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bilateral simple orchidectomy (BSO) | Experimental | The patients would have the testis, epididymis and distal cord structures excised Receives: Procedure: Bilateral simple orchidectomy (BSO) |
| Subcapsular orchidectomy (BSCO) | Experimental | 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 Receives: Procedure: Bilateral Subcapsular Orchidectomy |
| Epididymal-sparing orchidectomy (BESO) | Experimental | 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 Receives: Procedure: Bilateral Epididymal-sparing Orchidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: three months after the orchidectomy
Secondary outcomes (2)
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.
Measured: 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).
Measured: Three months (timed interval sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start2 Mar 2016
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of patients subjected to a type of orchidectomy each
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital, Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I.N. Chibuzo, University College Hospital, Ibadan
- Investigators
- Ijeoma NC Chibuzo, MBBS, MSc, Principal investigator, University College Hospital, Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744494
- Sponsor's protocol ID
- 15/0424
- Acronym
- TEPSO
- Status last verified
- May 2023
- First submitted
- 30 Jul 2018
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34868687
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03744494
- Acronym / sponsor ID
- TEPSO / 15/0424
- Conditions
- Prostate Cancer, Quality of Life, Orchiectomy
- Keywords
- orchidectomy, pseudotesticle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University College Hospital, IbadanUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups of patients subjected to a type of orchidectomy each
| Arm | Type | Receives |
|---|---|---|
| Bilateral simple orchidectomy (BSO) | Experimental | Procedure: Bilateral simple orchidectomy (BSO)The patients would have the testis, epididymis and distal cord structures excised |
| Subcapsular orchidectomy (BSCO) | Experimental | Procedure: Bilateral Subcapsular OrchidectomyThe 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 |
| Epididymal-sparing orchidectomy (BESO) | Experimental | Procedure: Bilateral Epididymal-sparing OrchidectomyThe 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive consenting patients with histologically confirmed locally advanced or metastatic PCa who have accepted to have an orchidectomy
Key exclusion criteria (2 listed)
- Patients who have had bilateral orchidectomy
- Those who opt for medical castration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral simple orchidectomy (BSO) | Procedure or surgery | Bilateral simple orchidectomy (BSO) |
| Bilateral Subcapsular Orchidectomy | Procedure or surgery | Subcapsular orchidectomy (BSCO) |
| Bilateral Epididymal-sparing Orchidectomy | Procedure or surgery | Epididymal-sparing orchidectomy (BESO) |
Primary outcome
Summative and domain quality of life scores
Time frame: Three months
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.
Summative and domain quality of life scores
Time frame: Three months
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.
Change in pseudotesticular volume
Time frame: Three months
A Prader orchidometer was used to measure the pre-operative testicular volume and post-operative pseudotesticular volume in cm3
Satisfaction with scrotal appearance
Time frame: three months after the orchidectomy
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
2 secondary outcomes
Serum PSA levels
Time frame: Three months (timed interval sampling)
Serum testosterone levels
Time frame: Three months (timed interval sampling)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Results publication: PubMed 34868687Chibuzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ijeoma NC Chibuzo, MBBS, MSc principal investigator
University College Hospital, Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral simple orchidectomy (BSO), Bilateral Subcapsular Orchidectomy and Bilateral Epididymal-sparing Orchidectomy in people with Prostate Cancer and Quality of Life, run by University College Hospital, Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summative and domain quality of life scores (time frame: Three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.