Advanced Prostate CancerNCT03701659
TUPKRP Combined With MAB Therapy for LUTS/PCa
A study testing Surgery combinate with Endocrine therapy and Endocrine therapy in people with Advanced Prostate Cancer and Lower Urinary Tract Symptoms, run by The Third Xiangya Hospital of Central South University.
Trial summary
Prostate cancer (PCa) is the second most frequently diagnosed cancer in men worldwide, accounting for 15% of all male cancers. In 2015, there were 220,800 estimated new cases of prostate cancer and 27,540 deaths by PCa, making this disease the second leading cause of cancer-related death for North American men. Read more about this study
- Who is it for?
- Ages 50 to 79 years, men only
- Conditions the study is for
- Advanced Prostate Cancer, Lower Urinary Tract Symptoms, Quality of Life
- What is being tested?
- Surgery combinate with Endocrine therapy and Endocrine therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 30 Nov 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 50 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hormone sensibility advanced prostate adenocarcinoma, clinical stages are T3-4N0-1M0-1b；
- International prostate symptom score is equal to or greater than 20;
- Maximum flow rate is equal to or less than 10ml/s, or bladder outlet obstruction is diagnosed by urodynamics
- Any of the following complication: ① calculus in bladder; ② Recurrent urinary tract infections; ③Inguinal hernia; ④vesicoureteral reflux
- The physical status score of the Eastern Cancer Cooperative Group (ECOG) is 0 or 1;
- There has been no previous evidence of malignancy in the past five years.
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- The patient is in good physical condition and able to tolerate anesthesia and surgery;
- There are no allergic reactions and liver or kidney function damage to endocrine drugs;
- Ability to take and retain medicines;
- Ability to follow study visit schedules and other program requirements；
- Be able to understand the character and purpose of the study, including possible risks and side effects; Be able to work with researchers and follow the requirements of the entire study;
- Ability to sign and date informed of the full character and purpose of the study, including possible risks and side effects, and sufficient time and opportunity to read and understand the information about this study.
Who cannot join
- Patients with castration-resistant prostate cancer;
- The physical status score of East Cancer cooperative Group is equal to or greater than 2;
- There has been previous evidence of other malignancy in the past five years;
- Patients with high coagulation and cannot stop taking anticoagulants;
- Abnormal coagulation function such as hemophilia;
- The patients are in poor physical condition and cannot tolerate anesthesia and surgery;
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- The patients have allergy or toxic side effects and other adverse reaction to endocrine drug;
- Patients with active tuberculosis or other fulminating infectious disease;
- Patients with immunodeficiency;
- Patients with the lower limb and joint function abnormality, cannot maintain the lithotomy position for a long time;
- Patients with urethral stricture;
- Unable to comply with study visit schedule and other program requirements;
- Any patients, who are regarded cannot not participate in the study;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multi-center Clinical Study of Palliative Transurethral Plasma Kinetic Resection of Prostate (TUPKRP) Combined With Endocrine Therapy for Advanced Prostate Cancer Complicated With Severe Lower Urinary Tract Symptoms
Prostate cancer (PCa) is the second most frequently diagnosed cancer in men worldwide, accounting for 15% of all male cancers. In 2015, there were 220,800 estimated new cases of prostate cancer and 27,540 deaths by PCa, making this disease the second leading cause of cancer-related death for North American men.
Men with PCa may develop lower urinary tract symptoms (LUTS) when prostate tumors invade or compress the prostatic urethra, the bladder or the neurovascular bundles, or when the prostate is enlarged. It has been estimated that over 40% of men with PCa experience moderate or severe LUTS. LUTS can impact profoundly on a man's quality of life (QoL); an effect that increases with increasing LUTS severity.
Read more
Transurethral resection of prostate (TURP) can offer immediate relief of the obstruction in patients with benign prostatic hyperplasia (BPH). In contrast, palliative TURP (p-TURP) (the so-called "channel" TURP), is transurethral resection of prostate tissue in a patient with metastatic or locally advanced and/or previously treated PCa to alleviate obstructive voiding symptoms.
Al¬though TURP is commonly performed to relieve bladder outlet ob¬struction (BOO) symptoms in patients with BPH, little known about the outcome of palliative transurethral plasma kinetic resection of prostate (p-TUPKRP) in patients with ad-vanced PCa.
Gonadotropin-releasing hormone (GnRH) agonists as androgen deprivation therapy (ADT) are the standard treatment for many patients with PCa, particularly those with advanced or metastatic disease. The impact of ADT on tumor control and achieving the reduction in prostate specific antigen (PSA) is well established. But there is less information available on the effects on LUTSs in men with PCa. Some short-term studies of ADT with the GnRH antagonist or with ADT in the neoadjuvant setting have demonstrated reductions in LUTSs, measured by the International Prostate Symptom Score (IPSS). There are few published data on the longer-term effects of ADT on LUTSs, apart from an earlier interim analysis of data from the current study.
In this study, p-TUPKRP combined with ADT will perform for 50 patients with advanced PCa complicated with severe LUTS. As a control, other 50 advanced PCa patients with same symptoms will be treated with ADT only. Some clinical data, including PSA, IPSS, QoL, Urinary flow rate (UFR), ECOG Score, Overall survival (OS), progression-free survival (PFS), will be analyzed. It is expected to explore the efficacy and safety of the combination therapy to advanced PCa with severe LUTS.
- Conditions
- Advanced Prostate Cancer, Lower Urinary Tract Symptoms, Quality of Life, Overall Survival, Progression of Prostate Cancer
- Being tested
- Surgery combinate with Endocrine therapy, Endocrine therapy
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery combinate with Endocrine therapyProcedure or surgery
TUPKRP is abbreviation of transurethral plasma kinetic resection of prostate, which is an effective treatment of bladder outlet obstruction for benign prostate hyperplasia. MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrinotherapy for advanced prostate cancer.
Endocrine therapyDrug
MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrine therapy for advanced prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| TUPKRP+MAB Group | Experimental | These patient will be treated by TUPKRP and MAB. Receives: Procedure: Surgery combinate with Endocrine therapy |
| MAB Group | Active comparator | These patient will be treated by MAB only. Receives: Drug: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA
Prostate specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The blood level of PSA is often elevated in men with prostate cancer. PSA will be used to evaluate the effectiveness of tumor therapy
Measured: 3 months
Maximum flow rate
Uronary flow rate is the volumetric flow rate of urine during urination. It is a measure of the quantity of urine excreted in a specified period of time (per second or per minute). It is measured with uroflowmetry, a type of flowmetry. The "Q" (a conventional symbol for flow rate) is used as a symbol for urine flow rate. Qmax indicates the maximum flow rate. Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate puts pressure on the urethra,
Measured: 3 months
IPSS
International prostate symptom score(IPSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).
Measured: 3 months
QoL
Quality of life due to urinary symptoms is base on the question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 6. Although this single question may or may not capture the global impact of benign prostatic hyperplasia (BPH) Symptoms or quality of life, it may serve as a valuable starting point for a doctor-patient conversation.
Measured: 3 months
ECOG
Physical status scores of East Cancer cooperative Group. Grade 0:Fully active, able to carry on all pre-disease performance without restriction; Grade 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2:Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; Grade 3:Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; Grade 5: dead.
Measured: 3 months
MRI
Magnetic Resonance Imaging (MRI) of the prostate uses a powerful magnetic field, radio waves and a computer to produce detailed pictures of the structures within a man's prostate gland. It is primarily used to evaluate the extent of prostate cancer and determine whether it has spread. MRI of the prostate can be used to determine the efficacy of therapy and imaging progression-free survival.
Measured: 6 months
SPECT
In prostate cancer, bone is the second most common site of metastatic disease after lymph nodes. Single-Photon Emission Computed Tomography (SPECT) in imaging bone metastases is increasing in popularity for staging newly diagnosed prostate cancer and for assessing response to therapy. SPECT can be used to determine the efficacy of therapy and imaging progression-free survival.
Measured: 6 months
PVR
PVR is post void residual urine volume. In those who can void, incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume < 50 mL is normal.
Measured: 3 months
OS
Overall survival, or OS, the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Measured: 12 months
PFS
Progression-free survival (PFS) is "the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse"
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijun Huang, MD, Study director, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701659
- Sponsor's protocol ID
- xy3yyUrology01
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 10 Oct 2018
- 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 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Clinical Study of Palliative Transurethral Plasma Kinetic Resection of Prostate (TUPKRP) Combined With Endocrine Therapy for Advanced Prostate Cancer Complicated With Severe Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT03701659
- Acronym / sponsor ID
- xy3yyUrology01
- Conditions
- Advanced Prostate Cancer, Lower Urinary Tract Symptoms, Quality of Life, Overall Survival, Progression of Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Oct 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.
Prostate cancer (PCa) is the second most frequently diagnosed cancer in men worldwide, accounting for 15% of all male cancers. In 2015, there were 220,800 estimated new cases of prostate cancer and 27,540 deaths by PCa, making this disease the second leading cause of cancer-related death for North American men.
Men with PCa may develop lower urinary tract symptoms (LUTS) when prostate tumors invade or compress the prostatic urethra, the bladder or the neurovascular bundles, or when the prostate is enlarged. It has been estimated that over 40% of men with PCa experience moderate or severe LUTS. LUTS can impact profoundly on a man's quality of life (QoL); an effect that increases with increasing LUTS severity.
Transurethral resection of prostate (TURP) can offer immediate relief of the obstruction in patients with benign prostatic hyperplasia (BPH). In contrast, palliative TURP (p-TURP) (the so-called "channel" TURP), is transurethral resection of prostate tissue in a patient with metastatic or locally advanced and/or previously treated PCa to alleviate obstructive voiding symptoms.
Al¬though TURP is commonly performed to relieve bladder outlet ob¬struction (BOO) symptoms in patients with BPH, little known about the outcome of palliative transurethral plasma kinetic resection of prostate (p-TUPKRP) in patients with ad-vanced PCa.
Gonadotropin-releasing hormone (GnRH) agonists as androgen deprivation therapy (ADT) are the standard treatment for many patients with PCa, particularly those with advanced or metastatic disease. The impact of ADT on tumor control and achieving the reduction in prostate specific antigen (PSA) is well established. But there is less information available on the effects on LUTSs in men with PCa. Some short-term studies of ADT with the GnRH antagonist or with ADT in the neoadjuvant setting have demonstrated reductions in LUTSs, measured by the International Prostate Symptom Score (IPSS). There are few published data on the longer-term effects of ADT on LUTSs, apart from an earlier interim analysis of data from the current study.
In this study, p-TUPKRP combined with ADT will perform for 50 patients with advanced PCa complicated with severe LUTS. As a control, other 50 advanced PCa patients with same symptoms will be treated with ADT only. Some clinical data, including PSA, IPSS, QoL, Urinary flow rate (UFR), ECOG Score, Overall survival (OS), progression-free survival (PFS), will be analyzed. It is expected to explore the efficacy and safety of the combination therapy to advanced PCa with severe LUTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUPKRP+MAB Group | Experimental | Procedure: Surgery combinate with Endocrine therapyThese patient will be treated by TUPKRP and MAB. |
| MAB Group | Active comparator | Drug: Endocrine therapyThese patient will be treated by MAB only. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hormone sensibility advanced prostate adenocarcinoma, clinical stages are T3-4N0-1M0-1b；
- International prostate symptom score is equal to or greater than 20;
- Maximum flow rate is equal to or less than 10ml/s, or bladder outlet obstruction is diagnosed by urodynamics
- Any of the following complication: ① calculus in bladder; ② Recurrent urinary tract infections; ③Inguinal hernia; ④vesicoureteral reflux
- The physical status score of the Eastern Cancer Cooperative Group (ECOG) is 0 or 1;
Key exclusion criteria (13 listed)
- Patients with castration-resistant prostate cancer;
- The physical status score of East Cancer cooperative Group is equal to or greater than 2;
- There has been previous evidence of other malignancy in the past five years;
- Patients with high coagulation and cannot stop taking anticoagulants;
- Abnormal coagulation function such as hemophilia;
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 |
|---|---|---|
| Surgery combinate with Endocrine therapyTUPKRP is abbreviation of transurethral plasma kinetic resection of prostate, which is an effective treatment of bladder outlet obstruction for benign prostate hyperplasia. MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrinotherapy for advanced prostate cancer. | Procedure or surgery | TUPKRP+MAB Group |
| Endocrine therapyMAB is abbreviation of Maximal androgen blockade, which is a kind of endocrine therapy for advanced prostate cancer. | Drug | MAB Group |
Primary outcome
PSA
Time frame: 3 months
Prostate specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The blood level of PSA is often elevated in men with prostate cancer. PSA will be used to evaluate the effectiveness of tumor therapy
Maximum flow rate
Time frame: 3 months
Uronary flow rate is the volumetric flow rate of urine during urination. It is a measure of the quantity of urine excreted in a specified period of time (per second or per minute). It is measured with uroflowmetry, a type of flowmetry. The "Q" (a conventional symbol for flow rate) is used as a symbol for urine flow rate. Qmax indicates the maximum flow rate. Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate puts pressure on the urethra,
IPSS
Time frame: 3 months
International prostate symptom score(IPSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).
QoL
Time frame: 3 months
Quality of life due to urinary symptoms is base on the question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from "delighted" to "terrible" or 0 to 6. Although this single question may or may not capture the global impact of benign prostatic hyperplasia (BPH) Symptoms or quality of life, it may serve as a valuable starting point for a doctor-patient conversation.
ECOG
Time frame: 3 months
Physical status scores of East Cancer cooperative Group. Grade 0:Fully active, able to carry on all pre-disease performance without restriction; Grade 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2:Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; Grade 3:Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; Grade 5: dead.
MRI
Time frame: 6 months
Magnetic Resonance Imaging (MRI) of the prostate uses a powerful magnetic field, radio waves and a computer to produce detailed pictures of the structures within a man's prostate gland. It is primarily used to evaluate the extent of prostate cancer and determine whether it has spread. MRI of the prostate can be used to determine the efficacy of therapy and imaging progression-free survival.
SPECT
Time frame: 6 months
In prostate cancer, bone is the second most common site of metastatic disease after lymph nodes. Single-Photon Emission Computed Tomography (SPECT) in imaging bone metastases is increasing in popularity for staging newly diagnosed prostate cancer and for assessing response to therapy. SPECT can be used to determine the efficacy of therapy and imaging progression-free survival.
PVR
Time frame: 3 months
PVR is post void residual urine volume. In those who can void, incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume < 50 mL is normal.
OS
Time frame: 12 months
Overall survival, or OS, the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
PFS
Time frame: 12 months
Progression-free survival (PFS) is "the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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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.
Zhijun Huang, MD study director
The Third Xiangya Hospital of Central South University
Questions about this trial
What is this clinical trial studying?
A study testing Surgery combinate with Endocrine therapy and Endocrine therapy in people with Advanced Prostate Cancer and Lower Urinary Tract Symptoms, run by The Third Xiangya Hospital of Central South University.
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 12 inclusion and 13 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Leye He, MD (+86 13574118619, heleye@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA (time frame: 3 months). The study lists 10 primary outcomes in all. 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 Oct 2018.