Prostate CancerP-RALPNCT06624813
Partial Prostatectomy for Prostate Cancer
A study testing Robot-assisted partial prostatectomy in people with Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
A phase 2 study investigation of safety and feasibility of partial prostatectomy for localized prostate cancer of intermediate risk at ICESP. It will be included 50 patients that have coincident findings of prostate cancer site on prostate biopsy and a suspicious area in the magnetic resonance imaging of the prostate… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Robot-assisted partial prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2024to Dec 2025
- 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 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with prostate cancer that presents an institutional (ICESP) fusion biopsy (cognitive or target) that presents
- Fusion-guided prostate biopsy with mpMRI performed at the São Paulo State Cancer Institute, which
- Present fragments for ISUP group grade (GG) ≤ 3 in only one of the prostate lobes
- Multiparametric prostate resonance with PIRADS 3 - 5 and which is in agreement with the laterality of the tumor in the prostate biopsy
- Life expectancy ≥ 10 years according to the Charlson score
- Absence of second primary cancer under active treatment. Patients treated for cancer from other sites for more than 5 years and without evidence of disease will be allowed
- Able to read, understand and complete the informed consent related to the research, as well as the research questionnaires on quality of life and functional parameters on erection and urinary continence
Who cannot join
- Patients with prostate cancer with an histology different from adenocarcinoma
- Suspicion of lymph node metastasis on mpMRI or distant bone scintigraphy
- definitive signs of extraprostatic extension on mpMRI
- history of pelvic/prostatic radiotherapy
- ISUP grade group ≥ 4
- Laterality of prostate biopsy discordant with mpMRI findings
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Insituto do Câncer do Estado de São Paulo
São Paulo
Rafael Coelho, MD-PhD, +55(11) 3893-2000, coelhouro@yahoo.com.br
Rafael Coelho, MD-PhD
About this study
Official title: Partial Robot-assisted Laparoscopic Prostatectomy for Intermediate Risk Prostate Cancer
A phase 2 study investigation of safety and feasibility of partial prostatectomy for localized prostate cancer of intermediate risk at ICESP. It will be included 50 patients that have coincident findings of prostate cancer site on prostate biopsy and a suspicious area in the magnetic resonance imaging of the prostate (PIRADS 3, 4 or 5).
Read the detailed description
This Phase 2 study aims to evaluate the feasibility and standardization of robotic partial prostatectomy in patients with localized intermediate-risk prostate cancer. The study will enroll 50 patients who have undergone prostate biopsies, categorized as Gleason grade group 2 or 3, with image-guided fusion at the Cancer Institute of the State of São Paulo. Eligible patients must also have a multiparametric prostate MRI (mpMRI) with a PIRADS score of 3 to 5, consistent with the biopsy laterality.
Surgeries will be performed at the Cancer Institute of the State of São Paulo by a high-volume robotic surgeon (Rafael Ferreira Coelho) using the da Vinci surgical system. Patients involved in this research will receive follow-up care in a specialized outpatient clinic, where multidisciplinary teams will administer questionnaires assessing urinary function, sexual function, perioperative pain, and quality of life, both preoperatively and postoperatively. Data will be collected in person and stored on the online REDCap® platform.
Postoperative complications will be classified and assessed using the Clavien-Dindo scale during the first 90 days following surgery. Oncological follow-up will include quarterly PSA tests in the first year, every four months in the second year, and semi-annually from the third year onward, continuing until the end of the five-year follow-up period. A new mpMRI and protocol biopsy of the remaining prostate lobe will be performed at the 6th and 12th month of follow-up, respectively.
Patients with negative biopsies for residual neoplasia will continue to be monitored with PSA. If residual neoplasia is detected, complementary treatment will be administered based on a shared decision-making process between the physician and the patient. This study will be conducted in compliance with Resolution 466/2012 of the National Health Council/Ministry of Health (CNS/MS) and the Declaration of Helsinki (2000), following approval from the Research Ethics Committee on Human Beings (CEPSH).
The study anticipates that patients treated under this protocol will achieve satisfactory oncological outcomes, with minimal impact on functional aspects such as urinary incontinence or sexual dysfunction, and low rates of postoperative complications or negative effects on quality of life.
- Conditions
- Prostate Cancer
- Being tested
- Robot-assisted partial prostatectomy
- Keywords
- partial prostatectomy in prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted partial prostatectomyProcedure or surgery
Also called Robot-assisted partial prostatectomy in patients with prostate cancer
Focal therapy with surgery for single lobe prostate cancer, partial robot-assisted partial prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Partial prostatectomy | Experimental | Robot-assisted partial prostatectomy in patients with prostate cancer Receives: Procedure: Robot-assisted partial prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year postoperative retreatment-free survival
Rate of patients who are free from additional treatment for the reminiscent prostatic lobe
Measured: 5 years
Secondary outcomes (8)
Sexual Health Inventory for Men (SHIM)
- Each question is scored from 1 to 5, with the total score ranging from 5 to 25. Higher scores indicate better erectile function.
Measured: 3rd, 6th, 12th, 18th and 24th months
American Urological Association Symptom Index - International Prostate Symptom Score (AUA-IPSS)
- Each symptom question is scored from 0 to 5, with the total symptom score ranging from 0 to 35. Higher scores indicate more Lower Urinary Tract Symptoms;
Measured: 3rd, 6th, 12th, 18th and 24th months
Expanded Prostate Cancer Index Composite
- EPIC is a comprehensive questionnaire designed to assess the health-related quality of life in men undergoing treatment for prostate cancer. EPIC evaluates a broad range of symptoms and concerns that men may experience before, during, and after treatment. It provides a detailed assessment of urinary, bowel, sexual, and hormonal domains, each of which is scored and can be transformed to a scale of 0 to 100. Higher scores indicate better health-related quality of life or fewer symptoms.
Measured: 3rd, 6th, 12th, 18th and 24th months
Quality of life: EuroQol-5D
EuroQol, often referred to as EQ-5D, is a standardized instrument developed by the EuroQol Group to measure health-related quality of life.
EQ-5D: The responses to the five dimensions can be combined into a single index value representing the health status. The resulting index value reflects the health-related quality of life on a scale from less than 0 to 1, where 1 represents perfect health, 0 represents a health state equivalent to being dead, and negative values represent health states perceived as worse than being dead.
Measured: 3rd, 6th, 12th, 18th and 24th months
prostate specific antigen kinetics
- PSA blood levels, measured by ng/mL
Measured: 3rd, 6th, 12th, 18th, 24th, 30th, 36th, 42th, 48th, 54 and 60 months
new magnetic resonance imaging per protocol at 6th month
Magnetic resonance imaging (MRI) reporting PIRADS score (Prostate Imaging-Reporting and Data System), categorical classification from 1 to 5, higher values meaning higher probability of a clinically significant prostate cancer
Measured: 6th month
new postoperative prostate biopsy on the residual prostatic lobe
Classified as negative for neoplasia or according with the ISUP (International Society of Urological Pathology) classification system, also known as the ISUP Gleason grade group. It is a refined method for grading prostate cancer based on its microscopic appearance. It categorizes prostate cancer into five grade groups, ranging from Grade Group 1 (least aggressive, corresponding to Gleason score ≤ 6) to Grade Group 5 (most aggressive, corresponding to Gleason scores 9-10). This classification helps predict the cancer's aggressiveness and guides treatment decisions, with lower grade groups often managed with active surveillance and higher grade groups requiring more aggressive treatment due to higher risks of progression and metastasis.
Measured: 12th month
Postoperative complications within 90 days of surgery
Number of participants with treatment-related adverse events as assessed by Calvin-Dindo classification
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624813
- Sponsor's protocol ID
- ICESP (CCEP ICESP 4017/23)
- Other IDs
- BRAZILIAN MINISTRY OF HEALTH
- Acronym
- P-RALP
- Status last verified
- Mar 2024
- First submitted
- 19 Apr 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Robot-assisted Laparoscopic Prostatectomy for Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06624813
- Acronym / sponsor ID
- P-RALP / ICESP (CCEP ICESP 4017/23)
- Conditions
- Prostate Cancer
- Keywords
- partial prostatectomy in prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Oct 2024 (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.
A phase 2 study investigation of safety and feasibility of partial prostatectomy for localized prostate cancer of intermediate risk at ICESP. It will be included 50 patients that have coincident findings of prostate cancer site on prostate biopsy and a suspicious area in the magnetic resonance imaging of the prostate (PIRADS 3, 4 or 5).
Detailed description
This Phase 2 study aims to evaluate the feasibility and standardization of robotic partial prostatectomy in patients with localized intermediate-risk prostate cancer. The study will enroll 50 patients who have undergone prostate biopsies, categorized as Gleason grade group 2 or 3, with image-guided fusion at the Cancer Institute of the State of São Paulo. Eligible patients must also have a multiparametric prostate MRI (mpMRI) with a PIRADS score of 3 to 5, consistent with the biopsy laterality.
Surgeries will be performed at the Cancer Institute of the State of São Paulo by a high-volume robotic surgeon (Rafael Ferreira Coelho) using the da Vinci surgical system. Patients involved in this research will receive follow-up care in a specialized outpatient clinic, where multidisciplinary teams will administer questionnaires assessing urinary function, sexual function, perioperative pain, and quality of life, both preoperatively and postoperatively. Data will be collected in person and stored on the online REDCap® platform.
Postoperative complications will be classified and assessed using the Clavien-Dindo scale during the first 90 days following surgery. Oncological follow-up will include quarterly PSA tests in the first year, every four months in the second year, and semi-annually from the third year onward, continuing until the end of the five-year follow-up period. A new mpMRI and protocol biopsy of the remaining prostate lobe will be performed at the 6th and 12th month of follow-up, respectively.
Patients with negative biopsies for residual neoplasia will continue to be monitored with PSA. If residual neoplasia is detected, complementary treatment will be administered based on a shared decision-making process between the physician and the patient. This study will be conducted in compliance with Resolution 466/2012 of the National Health Council/Ministry of Health (CNS/MS) and the Declaration of Helsinki (2000), following approval from the Research Ethics Committee on Human Beings (CEPSH).
The study anticipates that patients treated under this protocol will achieve satisfactory oncological outcomes, with minimal impact on functional aspects such as urinary incontinence or sexual dysfunction, and low rates of postoperative complications or negative effects on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial prostatectomy | Experimental | Procedure: Robot-assisted partial prostatectomyRobot-assisted partial prostatectomy in patients with prostate cancer |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with prostate cancer that presents an institutional (ICESP) fusion biopsy (cognitive or target) that presents
- Fusion-guided prostate biopsy with mpMRI performed at the São Paulo State Cancer Institute, which
- Present fragments for ISUP group grade (GG) ≤ 3 in only one of the prostate lobes
- Multiparametric prostate resonance with PIRADS 3 - 5 and which is in agreement with the laterality of the tumor in the prostate biopsy
- Life expectancy ≥ 10 years according to the Charlson score
Key exclusion criteria (6 listed)
- Patients with prostate cancer with an histology different from adenocarcinoma
- Suspicion of lymph node metastasis on mpMRI or distant bone scintigraphy
- definitive signs of extraprostatic extension on mpMRI
- history of pelvic/prostatic radiotherapy
- ISUP grade group ≥ 4
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 |
|---|---|---|
| Robot-assisted partial prostatectomyAlso: Robot-assisted partial prostatectomy in patients with prostate cancerFocal therapy with surgery for single lobe prostate cancer, partial robot-assisted partial prostatectomy | Procedure or surgery | Partial prostatectomy |
Primary outcome
Five-year postoperative retreatment-free survival
Time frame: 5 years
Rate of patients who are free from additional treatment for the reminiscent prostatic lobe
8 secondary outcomes
Sexual Health Inventory for Men (SHIM)
Time frame: 3rd, 6th, 12th, 18th and 24th months
American Urological Association Symptom Index - International Prostate Symptom Score (AUA-IPSS)
Time frame: 3rd, 6th, 12th, 18th and 24th months
Expanded Prostate Cancer Index Composite
Time frame: 3rd, 6th, 12th, 18th and 24th months
Quality of life: EuroQol-5D
Time frame: 3rd, 6th, 12th, 18th and 24th months
prostate specific antigen kinetics
Time frame: 3rd, 6th, 12th, 18th, 24th, 30th, 36th, 42th, 48th, 54 and 60 months
new magnetic resonance imaging per protocol at 6th month
Time frame: 6th month
new postoperative prostate biopsy on the residual prostatic lobe
Time frame: 12th month
Postoperative complications within 90 days of surgery
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted partial prostatectomy in people with Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-year postoperative retreatment-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 3 Oct 2024.