Prostate CancerNCT05722392
Safety and Efficacy of Two-step Radical Prostatectomy
An observational study of Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Two-step Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 15 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia
Who may be able to join
- Diagnosed as prostate cancer pathologically by prostate biopsy
- Evaluated as localized prostate cancer by imaging studies
- Prostate volume>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
- Gleason score≤ 4+3=7
- Preoperative PSA<20ng/mL
- Estimated survival> 10 years；
- Informed consent is obtained from the patient
Who cannot join
- The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
- Any contraindication of surgery or anaesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yonghong Li, M.D., +020-87343656, liyongh@sysucc.org.cn
Fangjian Zhou, M.D., +020-87343656, zhoufj@sysucc.org.cn
About this study
Official title: An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia
The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?
- Conditions
- Prostate Cancer
- Being tested
- Two-step Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-step Radical ProstatectomyProcedure or surgery
The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland
| Study group | Role | What they receive |
|---|---|---|
| Two-step Radical Prostatectomy | Two-step Radical Prostatectomy Receives: Procedure: Two-step Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Recurrence-free Survival
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. Biochemical recurrence was defined as a measurable serum PSA concentration 0.2 ng/ml or greater.
Measured: 5 years
Secondary outcomes (10)
Surgical time
Defined as the time duration from the incision at the opening to the end of closing the incision
Measured: Intraoperative
Estimated blood loss
Defined as all the blood loss counting during the surgery
Measured: Intraoperative
Hospital stay
Defined as the time duration between the first day after surgery to the day of discharge
Measured: From date of surgery until the date of discharge, an average of 7 days
Continence
Evaluated with the use of pad per day. Using no more than 1 pad per day is defined as complete continence
Measured: 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery
Lower urinary tract symptoms
Evaluated with International Prostatic Symptom Score (IPSS). 1-7: Mild 8-19:Moderate 20-35: Severe
Measured: 1 months, 3 months, 6 months, 12 months after surgery
Erectile function
Evaluated with International Index of Erectile Function-5 (IIEF-5).The IIEF-5 score is the sum of the ordinal responses to the 5 items.
22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction
Measured: 6 months, 12 months and 24 months after surgery
Positive surgical margin rate
Defined as the proportion of patients with positive surgical margin of the whole prostate and the margin between the hyperplastic adenoma and the residual gland evaluated by pathologists. The location of positive margin will be documented.
Measured: Through study completion, an average of 5 year
Complication
All the complications which was evaluated relevant to the surgery will be documented and graded by Clavien-Dindo grade system.
Measured: Through study completion, an average of 5 year
Overall survival
Number of participants who are alive after a specified duration of time
Measured: From date of randomization until the date of date of death from any cause, assessed up to 60 months
Cancer-specific survival
Number of participants who are not dead due to prostate cancer after a specified duration of time
Measured: From date of randomization until the date of date of death from cancer, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion15 Feb 2033 (estimated)
- Study completion15 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonghong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722392
- Sponsor's protocol ID
- 2022-FXY-296
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05722392
- Acronym / sponsor ID
- 2022-FXY-296
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 15 Feb 2033 (estimated)
- Study completion
- 15 Feb 2033 (estimated)
- First posted
- 10 Feb 2023 (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 goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two-step Radical Prostatectomy | – | Procedure: Two-step Radical ProstatectomyTwo-step Radical Prostatectomy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia
Key inclusion criteria (7 listed)
- Diagnosed as prostate cancer pathologically by prostate biopsy
- Evaluated as localized prostate cancer by imaging studies
- Prostate volume>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
- Gleason score≤ 4+3=7
- Preoperative PSA<20ng/mL
Key exclusion criteria (2 listed)
- The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
- Any contraindication of surgery or anaesthesia
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 |
|---|---|---|
| Two-step Radical ProstatectomyThe first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland | Procedure or surgery | Two-step Radical Prostatectomy |
Primary outcome
Biochemical Recurrence-free Survival
Time frame: 5 years
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. Biochemical recurrence was defined as a measurable serum PSA concentration 0.2 ng/ml or greater.
10 secondary outcomes
Surgical time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Hospital stay
Time frame: From date of surgery until the date of discharge, an average of 7 days
Continence
Time frame: 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery
Lower urinary tract symptoms
Time frame: 1 months, 3 months, 6 months, 12 months after surgery
Erectile function
Time frame: 6 months, 12 months and 24 months after surgery
Positive surgical margin rate
Time frame: Through study completion, an average of 5 year
Complication
Time frame: Through study completion, an average of 5 year
Overall survival
Time frame: From date of randomization until the date of date of death from any cause, assessed up to 60 months
Cancer-specific survival
Time frame: From date of randomization until the date of date of death from cancer, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 10 Feb 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonghong Li, M.D. (020-87343656, liyongh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Recurrence-free Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2023.