Metastatic Prostate CancerPhase 2CTUSMEP01NCT06655259
Combination of TURP and Standard Systemic Therapy for MPCa
A Phase 2 study testing TURP and Standard Medical Therapy in people with Metastatic Prostate Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a Phase II, open-label, prospective, single-arm clinical study designed to evaluate the efficacy and safety of combining transurethral resection of the prostate (TURP) with standard systemic therapy in patients with metastatic prostate cancer (mPCa). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- TURP and Standard Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2024to Dec 2026
- Phase
- Phase 2
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must voluntarily agree to participate and provide signed informed consent.
- aged 18 to 80 years.
- Pathologically or cytologically confirmed adenocarcinoma of the prostate, with neuroendocrine differentiation components ≤10%, and no small cell or signet ring cell carcinoma histological features.
- Newly diagnosed metastatic prostate cancer with evidence of metastasis (lymph node, bone, or visceral metastases) confirmed by PSMA/PET-CT, CT, or MRI.
- Patients must not have participated in or plan to participate in another clinical trial.
- ECOG PS score of 0-1.
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- Adequate Organ and Bone Marrow Function:
- Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L (1500/μL).
- Hemoglobin ≥ 90 g/L (9.0 g/dL).
- Platelet count ≥ 80×10⁹/L (100,000/μL).
- Liver function: total bilirubin ≤ 1.5×ULN, AST/ALT and alkaline phosphatase ≤ 2.5×ULN.
- Ⅴ. Kidney function: serum creatinine ≤ 2×ULN or calculated creatinine clearance ≥ 30 mL/min.
- Ⅵ. Coagulation function: INR ≤ 1.5.
Who cannot join
- History of hypersensitivity or intolerance to any of the drugs used in the study.
- Patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have already undergone TURP and do not present with lower urinary tract obstruction or hematuria.
- Oligometastatic mHSPC Patients: Patients with oligometastatic hormone-sensitive prostate cancer (mHSPC) who are planning to undergo radical prostatectomy as the primary treatment.
- Patients with significant contraindications to TURP, such as severe urethral stricture or inability to catheterize.
- History of seizures or medications known to lower the seizure threshold, or any disease that may induce seizures (e.g., stroke or transient ischemic attacks) within 12 months prior to the study.
- Recent Major Surgery: Patients who have undergone major surgery within 4 weeks before starting the study treatment.
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- History of severe or unstable cardiovascular disease within the last 6 months, including severe angina, myocardial infarction, congestive heart failure (NYHA III or higher), cerebrovascular accident, or requiring medication for arrhythmia.
- Severe Digestive Disorders: Patients with chronic diarrhea, bowel obstruction, or other factors affecting drug absorption.
- Patients with active infections, including HIV, hepatitis B (HBsAg-positive), or hepatitis C, that may affect the safety and efficacy of the treatment.
- Patients diagnosed with other malignancies in the past 3 years, excluding cured basal cell carcinoma of the skin.
- Patients with active brain metastases or leptomeningeal disease.
- Patients currently receiving any investigational drugs or devices.
- Patients who are unlikely to comply with the treatment protocol and follow-up schedule.
- Any condition that the investigator believes could compromise the patient's safety or interfere with the study results (e.g., uncontrolled hypertension, severe diabetes, psychiatric conditions).
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye, MD., 86-21-64175590, dwyeli@163.com
Xiaojian Qin, MD., +86 18017317217, q@urocancer.org
About this study
Official title: An Open-Label, Prospective, Single-Arm Clinical, Phase II Study on the Efficacy and Safety of TURP Combined with Standard Systemic Therapy in Patients with Metastatic Prostate Cancer
This is a Phase II, open-label, prospective, single-arm clinical study designed to evaluate the efficacy and safety of combining transurethral resection of the prostate (TURP) with standard systemic therapy in patients with metastatic prostate cancer (mPCa). All participants will undergo TURP to relieve urinary obstruction and reduce tumor burden, followed by androgen deprivation therapy (ADT) and second-generation anti-androgen agents, such as abiraterone or enzalutamide. The primary outcome is radiographic progression-free survival (rPFS), with secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), PSA response rates at 3 and 6 months, and quality of life assessments. The trial will enroll 200 newly diagnosed metastatic prostate cancer patients, with regular follow-up for monitoring disease progression and treatment safety. The study will be conducted at Fudan University Cancer Hospital.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- TURP, Standard Medical Therapy
- Keywords
- mPCa, TURP, ADT, rPFS, prognosis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPProcedure or surgery
Participants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor
Standard Medical TherapyDrug
Participants will receive Standard Medical Therapy, which includes ADT, typically with an LHRH agonist or antagonist, to reduce testosterone levels, a key driver of prostate cancer progression. In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide. These medications block androgen receptor signaling and further inhibit the cancer\'s ability to grow.
| Study group | Role | What they receive |
|---|---|---|
| TURP Combined with Standard Systemic Therapy | Experimental | Participants in this arm will undergo Transurethral Resection of the Prostate (TURP) to alleviate urinary obstruction and reduce tumor burden, followed by Standard Systemic Therapy. This includes Androgen Deprivation Therapy (ADT) with either an LHRH agonist or antagonist, combined with a second-generation anti-androgen, such as abiraterone or enzalutamide, depending on the patient's condition. The goal is to assess the efficacy and safety of this combined approach in treating patients with metastatic prostate cancer (mPCa). Receives: Procedure: TURP; Drug: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-Free Survival (rPFS)
Defined as the time from the start of treatment to radiographic evidence of disease progression, assessed by imaging techniques such as PSMA PET-CT, MRI, or CT scans, following RECIST 1.1 criteria. The primary objective is to evaluate how long patients remain free from disease progression after receiving the combination of TURP and standard systemic therapy.
Measured: 2 years
Urinary Symptom Relief Rate
Urinary symptom relief will be assessed using the International Prostate Symptom Score (IPSS) and objective measures like urine flow rate. The goal is to evaluate the extent to which TURP alleviates urinary obstruction and related symptoms in patients with metastatic prostate cancer.
Measured: 2 years
Secondary outcomes (4)
Overall Survival (OS)
Defined as the time from the start of treatment until death from any cause. For patients who are still alive, the time will be censored at the last follow-up. This secondary outcome measure aims to assess the overall survival rate of patients receiving the combination of TURP and standard systemic therapy for metastatic prostate cancer, comparing survival outcomes over the course of the study.
Measured: 2 years
Biochemical Progression-Free Survival (bPFS)
Defined as the time from the start of treatment to biochemical progression, according to the criteria set by the American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA). Biochemical progression is typically defined as an increase in PSA (Prostate-Specific Antigen) level by 2 ng/mL or more above the nadir (lowest point). This measure will assess how long patients maintain PSA control after receiving the combination of TURP and standard systemic therapy.
Measured: 2 years
3-, 6-Months PSA Response Rate
The proportion of patients whose Prostate-Specific Antigen (PSA) levels decrease by more than 50% from baseline will be measured at 3 months and 6 months post-treatment. The PSA response rate will be assessed at both time points to evaluate the effectiveness of the combined TURP and standard systemic therapy in reducing PSA levels, which is a key marker of prostate cancer activity.
Measured: 3 and 6 months
Quality of Life Assessment
This outcome will evaluate changes in patients' quality of life using the EORTC QLQ-C30 questionnaire. It assesses physical, emotional, and social well-being during and after treatment. The score ranges from 0 to 100, with higher scores indicating a better quality of life.
Measured: Baseline, 3, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start21 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, prospective Phase II clinical trial. The model focuses on evaluating the combination of TURP (Transurethral Resection of the Prostate) and standard systemic therapy in patients newly diagnosed with metastatic prostate cancer (mPCa). All participants will receive TURP followed by androgen deprivation therapy (ADT), and second-generation anti-androgens such as abiraterone or enzalutamide. The study aims to assess both the efficacy and safety of this combined approach, with radiographic progression-free survival (rPFS) as the primary outcome, and secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), and PSA response. The trial is conducted at a single center with a targeted enrollment of 200 patients.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655259
- Sponsor's protocol ID
- 2409304-4
- Acronym
- CTUSMEP01
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 23 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective, Single-Arm Clinical, Phase II Study on the Efficacy and Safety of TURP Combined with Standard Systemic Therapy in Patients with Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06655259
- Acronym / sponsor ID
- CTUSMEP01 / 2409304-4
- Conditions
- Metastatic Prostate Cancer
- Keywords
- mPCa, TURP, ADT, rPFS, prognosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 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.
This is a Phase II, open-label, prospective, single-arm clinical study designed to evaluate the efficacy and safety of combining transurethral resection of the prostate (TURP) with standard systemic therapy in patients with metastatic prostate cancer (mPCa). All participants will undergo TURP to relieve urinary obstruction and reduce tumor burden, followed by androgen deprivation therapy (ADT) and second-generation anti-androgen agents, such as abiraterone or enzalutamide. The primary outcome is radiographic progression-free survival (rPFS), with secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), PSA response rates at 3 and 6 months, and quality of life assessments. The trial will enroll 200 newly diagnosed metastatic prostate cancer patients, with regular follow-up for monitoring disease progression and treatment safety. The study will be conducted at Fudan University Cancer Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, prospective Phase II clinical trial. The model focuses on evaluating the combination of TURP (Transurethral Resection of the Prostate) and standard systemic therapy in patients newly diagnosed with metastatic prostate cancer (mPCa). All participants will receive TURP followed by androgen deprivation therapy (ADT), and second-generation anti-androgens such as abiraterone or enzalutamide. The study aims to assess both the efficacy and safety of this combined approach, with radiographic progression-free survival (rPFS) as the primary outcome, and secondary outcomes including overall survival (OS), biochemical progression-free survival (bPFS), and PSA response. The trial is conducted at a single center with a targeted enrollment of 200 patients.
| Arm | Type | Receives |
|---|---|---|
| TURP Combined with Standard Systemic Therapy | Experimental | Procedure: TURP, Drug: Standard Medical TherapyParticipants in this arm will undergo Transurethral Resection of the Prostate (TURP) to alleviate urinary obstruction and reduce tumor burden, followed by Standard Systemic Therapy. This includes Androgen Deprivation Therapy (ADT) with either an LHRH agonist or antagonist, combined with a second-generation anti-androgen, such as abiraterone or enzalutamide, depending on the patient's condition. The goal is to assess the efficacy and safety of this combined approach in treating patients with metastatic prostate cancer (mPCa). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must voluntarily agree to participate and provide signed informed consent.
- aged 18 to 80 years.
- Pathologically or cytologically confirmed adenocarcinoma of the prostate, with neuroendocrine differentiation components ≤10%, and no small cell or signet ring cell carcinoma histological features.
- Newly diagnosed metastatic prostate cancer with evidence of metastasis (lymph node, bone, or visceral metastases) confirmed by PSMA/PET-CT, CT, or MRI.
- Patients must not have participated in or plan to participate in another clinical trial.
Key exclusion criteria (14 listed)
- History of hypersensitivity or intolerance to any of the drugs used in the study.
- Patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) who have already undergone TURP and do not present with lower urinary tract obstruction or hematuria.
- Oligometastatic mHSPC Patients: Patients with oligometastatic hormone-sensitive prostate cancer (mHSPC) who are planning to undergo radical prostatectomy as the primary treatment.
- Patients with significant contraindications to TURP, such as severe urethral stricture or inability to catheterize.
- History of seizures or medications known to lower the seizure threshold, or any disease that may induce seizures (e.g., stroke or transient ischemic attacks) within 12 months prior to the study.
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 |
|---|---|---|
| TURPParticipants will undergo Transurethral Resection of the Prostate (TURP), a surgical procedure performed to relieve symptoms of urinary obstruction caused by the prostate tumor | Procedure or surgery | TURP Combined with Standard Systemic Therapy |
| Standard Medical TherapyParticipants will receive Standard Medical Therapy, which includes ADT, typically with an LHRH agonist or antagonist, to reduce testosterone levels, a key driver of prostate cancer progression. In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide. These medications block androgen receptor signaling and further inhibit the cancer\'s ability to grow. | Drug | TURP Combined with Standard Systemic Therapy |
Primary outcome
Radiographic Progression-Free Survival (rPFS)
Time frame: 2 years
Defined as the time from the start of treatment to radiographic evidence of disease progression, assessed by imaging techniques such as PSMA PET-CT, MRI, or CT scans, following RECIST 1.1 criteria. The primary objective is to evaluate how long patients remain free from disease progression after receiving the combination of TURP and standard systemic therapy.
Urinary Symptom Relief Rate
Time frame: 2 years
Urinary symptom relief will be assessed using the International Prostate Symptom Score (IPSS) and objective measures like urine flow rate. The goal is to evaluate the extent to which TURP alleviates urinary obstruction and related symptoms in patients with metastatic prostate cancer.
4 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Biochemical Progression-Free Survival (bPFS)
Time frame: 2 years
3-, 6-Months PSA Response Rate
Time frame: 3 and 6 months
Quality of Life Assessment
Time frame: Baseline, 3, 6, 12, and 24 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 23 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TURP and Standard Medical Therapy in people with Metastatic Prostate Cancer, run by Fudan 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 13 inclusion and 14 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 23 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dingwei Ye, MD. (+862164175590, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-Free Survival (rPFS) (time frame: 2 years). The study lists 2 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 23 Oct 2024.