Plain English Summary
Background and study aims
Bladder cancer is where a tumour develops in the bladder lining. Patients who have high risk early bladder cancer, invasive bladder cancer or locally advanced bladder cancer may have to have their bladder removed (radical cystectomy). In women, sometimes the ovaries may also need to be removed (oophorectomy). There are at present no studies on whether oophorectomy should be performed with radical cystectomy as treatment for muscle-invasive bladder cancer in women. Information is also lacking regarding the effects on hormone levels and sexual function. The aim of this study is to assess the hormone levels and sexual function of women undergoing radical cystectomy with or without oophorectomy for bladder cancer.
Who can participate?
Women aged 18-85 undergoing radical cystectomy for bladder cancer
What does the study involve?
Participants are randomly allocated to undergo radical cystectomy with either no oophorectomy, removal of one ovary or removal of both ovaries. Sexual function and blood hormone levels are assessed at the start of the study and 12 and 52 weeks after the operation.
What are the possible benefits and risks of participating?
Participants allocated to no oophorectomy may benefit from better hormonal, sexual and general function after surgery. There are no risks in participating in this study.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
April 2017 to December 2020
Who is funding the study?
Hillevi Fries Foundation (Sweden)
Who is the main contact?
1. Dr Fredrik Liedberg
2. Dr George Jancke
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fredrik Liedberg
ORCID ID
http://orcid.org/0000-0001-8193-0370
Contact details
Department of Urology
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
Type
Scientific
Additional contact
Dr George Jancke
ORCID ID
Contact details
Department of Urology
Lund University
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-20502
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1/2017
Study information
Scientific title
Impact of oophorectomy at cystectomy for urinary bladder cancer on female hormonal status and sexual function: Randomized study on Oophorectomy at Cystectomy (ROC-study)
Acronym
ROC-study
Study hypothesis
Preservation of ovarian tissue increases sexual function and improves hormonal status after radical cystectomy.
Ethics approval
The Regional Ethical Review Board in Lund, 14/02/2017, ref: 2016/1036 and 2017/2
Study design
Prospective randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Bladder cancer treated with radical cystectomy
Intervention
Patients undergoing radical cystectomy will be randomized using closed envelopes to undergo either:
1. No oophorectomy
2. Excision of one ovary
3. Excision of both ovaries
Oophorectomy will be performed by standard surgical methods, including ligation of parametrium with Ligasure when preserving the one or two ovaries. Follow-up will be 12 months postoperatively according to the protocol, however clinical follow-up will be according to clinical routines.
Intervention type
Phase
Drug names
Primary outcome measure
1. Sexual function, measured using Female Sexual Function Index (FSFI) score at baseline, 12 and 52 weeks postoperatively
2. Hormonal status, measured using plasma levels of total testosterone, dihydrotestosterone, SHBG, anti-müllerian-hormone, androstenedione, dehydroepiandrosterone sulphate, progesterone, oestradiol (sensitive method for postmenopausal women), LH and FSH, at baseline, 12 and 52 weeks postoperatively
Secondary outcome measures
No secondary outcome measures
Overall trial start date
09/04/2017
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women undergoing radical cystectomy
2. Aged 18-85 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
360 female patients
Participant exclusion criteria
1. Clinical suspicion of tumour involvement of either ovaries
2. Previous radiation of the pelvis
3. Previous cystectomy
4. Previous oophorectomy
Recruitment start date
18/04/2017
Recruitment end date
31/12/2020
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University Hospital
Department of Urology
Malmö
SE-205 02
Sweden
Funders
Funder type
Charity
Funder name
Hillevi Fries Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study will be published in a urologic journal after closure.
IPD sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available due to integrity reasons for the participating patients.
Intention to publish date
31/12/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list