Prostatic NeoplasmsNCT05670691
a Study of Combined mpMRI and PSMA PET/CT for Highly Suspicious Patients Performing Radical Prostatectomy Without Biopsy
An observational study of Prostatic Neoplasms and Prostatectomy, run by Fudan University.
Trial summary
This is an observational, open, single-arm, prospective, staged entry（based on Fleming's Group-Sequential Design） clinical study The Goal is to evaluate the feasibility and clinical value of direct robot assisted laparoscopic radical prostatectomy without prostate biopsy in patients with high clinical suspicion of… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostatectomy, Prostate Biopsy
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2023to 1 Mar 2025
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Robotic-assisted laparoscopic radical prostate cancer surgery is recommended for this group of patients. Ultimately, the presence or absence of evidence of malignant prostate cancer on the pathology report after radical prostatectomy is used as an observational endpoint in this study. Relevant perioperative clinicopathological data are also collected according to the study objectives.
Who may be able to join
- age ≥ 18 years.
- consent and ability to complete a multiparametric MRI of the prostate.
- consent and ability to complete PSMA PET/CT.
- multiparametric MRI of the prostate with a PI-RADS score of 4 or 5 for suspicious lesions.
- Positive PSMA PET/CT. Its positive is defined as a suspicious lesion score of 2 or 3 (see remarks for specific scoring criteria).
- good physical condition with an ECOG score of 0 or 1.
Show all 12Show fewer
- no history of radiotherapy or other surgery to the pelvis
- the presence of pelvic lymph node enlargement (>2 cm) or metastasis is allowed; ≤5 bone and lymph node metastases are allowed
- the patient has good cardiac, pulmonary, hepatic and renal function and is able to tolerate local treatment (surgery or external radiotherapy) of the primary site and metastases, and the treatment will not cause serious complications for the patient.
- the patient participates voluntarily and has signed an informed consent form
- the patient is able to receive treatment and subsequent follow-up
- the expected survival time is greater than 1 year.
Who cannot join
- unwillingness or inability to perform multiparametric MRI of the prostate; or PI-RADS score of 0-3
- request for prostate puncture biopsy.
- unwillingness or inability to perform PSMA PET/CT; or PSMA PET/CT score of 0 or 1
- refusing radical prostate cancer surgery, or choosing other primary lesion treatment modalities other than radical prostate cancer surgery
- poor physical condition that prevents them from tolerating radical prostate cancer surgery
- More than 5 bone and lymph node metastases, visceral metastases
Show all 10Show fewer
- history of combined other malignant tumors (except basal cell carcinoma of the skin or other tumors that have been cured for more than 5 years)
- other serious medical conditions, such as: unstable heart disease after treatment, myocardial infarction within 6 months prior to treatment, cardiac function class 3-4 (NYHA); uncontrolled hypertension (>150/90 mmHg, severe neurological or psychological disorders including dementia or epilepsy) with medical treatment; uncontrolled active infection; acute gastric ulcer; hypercalcemia; chronic obstructive lung disease.
- have participated in other clinical studies prior to enrollment.
- Note: Positive PSMA PET/CT, defined as based on the miPSMA score scale suggested by the PROMISE Institute (score 0 - below the depth of blood contrast; score 1 - equal to or above the blood contrast and below the liver contrast; score 2 - equal to or above the liver contrast and below the parotid contrast; score 3 - equal to or above the liver parotid contrast.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Staged, Exploratory Clinical Study of Combined Multiparametric MRI and PSMA PET/CT for the Evaluation of Patients With High Suspicion of Prostate Cancer for Direct Radical Prostatectomy Without Prostate Biopsy
This is an observational, open, single-arm, prospective, staged entry（based on Fleming's Group-Sequential Design） clinical study
The Goal is to evaluate the feasibility and clinical value of direct robot assisted laparoscopic radical prostatectomy without prostate biopsy in patients with high clinical suspicion of prostate cancer based on a prostate MRI PI-RADS score of ≥4 and the PSMA PET/CT positive criteria.
Read more
The Primary endpoint is positive pathological diagnosis of prostate cancer after direct radical prostatectomy without prostate biopsy.
The question addressed is whether the feasibility of biopsy-free radical prostatectomy could be scientifically and rationally derived based on Fleming's Group-Sequential design.
Read the detailed description
Prostate biopsy is currently the key method for diagnosing prostate cancer. However, there are various risks associated with prostate biopsy. First, biopsy complications occur and usually include bleeding, infection, urinary retention, and vasovagal reflexes. Bleeding is one of the most common complications following prostate biopsy, with perineal biopsy hematuria occurring in 39%-44% of cases, rectal bleeding in 17%-27% of cases, and hematospermia in 12%-16% of cases. Infection is one of the more definite complications of prostate biopsy. The incidence is 5-12%. The probability of urinary retention after prostate biopsy is 0.5% to 1.7%. The vasovagal reflex is mainly characterized by a rapid drop in blood pressure, pallor, sweating, nausea, vomiting, chest tightness and, in severe cases, transient coma. The incidence is 0.9% to 16.7%. It is usually necessary to wait 2-4 weeks after biopsy before radical prostate cancer surgery can be performed. Therefore, timely treatment of the patient may be delayed. Second, the pain, anxiety and even fear associated with the biopsy are always with the patient. Third, the issuance of pathology reports generally takes 7-8 days and, if immunohistochemistry is involved, another 2 weeks, a long time with limited management of the full course of the disease, as well as patient attrition.
Multiparametric MRI (mpMRI) has a high tissue resolution and ideal specificity and sensitivity. mpMRI PI-RADS scores of 3, 4 and 5 were associated with a 35%, 60% and 91% diagnosis of prostate cancer, and furthermore, 17%, 34% and 67% diagnosis of CsPCa, respectively.
On the other hand, prostate-specific membrane antigen (PSMA) can specifically anchor prostate cancer cells and has a high sensitivity and specificity for detection.Studies have shown that 68Ga-PSMA PET/CT has a sensitivity of 88%-92% and a specificity of 92%-95% for the diagnosis of prostate cancer. In recent years, PET has also been combined with MRI to obtain many advantages in PET functional imaging as well as MRI imaging discrimination, which is more effective in improving the positive rate of impact diagnosis of prostate cancer.
The combined assessment of multiparametric MRI and PSMA PET/CT has greatly increased the likelihood of prostate cancer in people with multiple abnormalities, and on the other hand, the complications associated with prostate biopsy as well as the delay in surgery and the resulting increased difficulty of surgery. In December 2021, the European Journal of Urology first reported on radical surgery for prostate cancer without biopsy .
The investigators designed this clinical trial based on a combination of multiparametric MRI and PSMA PET/CT to evaluate patients with high suspicion of prostate cancer and make quantitative statistics. mpMRI and PSMA PET/CT were not only among the study parameters, but also could be satisfied with PSMA PET/CT, which was implemented after signing an informed consent after interpretation and performing a direct radical surgery without prostate biopsy.
More importantly, the investigators used Fleming's Group-Sequential Design for the first time, which met the sample size requirements while avoiding the dilemma of having to recruit more patients for the study.
Fleming's Group-Sequential Design
N=71，P0=0.900， P1=0.980 Alpha=0.0230 Power=0.8067
Stage; Sample Size; Cumulative Sample Size; Accept H0 if R ≤ Ag; Reject H0 if R ≥ Rg;
①. 24; 24; 22 27
②. 24; 48; 45 48
③. 23; 71; 68 69
Explanation and description of "Stage Results of Fleming's Group-Sequential Design":
(1) P0=0.900, defined as a pathologically minimum acceptable prostate cancer positivity rate of 90% in the population of patients undergoing biopsy-free radical prostatectomy.
- P1=0.980, defined as a pathologically desirable prostate cancer positivity rate of 98% in the population of patients undergoing biopsy-free radical prostatectomy.
- Based on the Fleming group sequential trial design idea, the sample size is calculated using PASS11 software, with 24 cases in the first stage, 24 cases in the second stage, and 23 cases in the third stage, for a total sample size of 71 cases.
- The protocol is implemented until the completion of the first phase a) If the number of positive cases of pathology after biopsy-free radical prostatectomy is ≤ 22, it indicates the end of this study and concludes that biopsy-free radical prostatectomy is not feasible.
- If the number of positive cases is 23 or 24, then proceed to the second phase.
- The protocol is implemented until the completion of the second phase a) If the number of positive cases is ≤45, it indicates the end of this study and concludes that biopsy-free radical prostatectomy is not feasible.
- If the number of positive cases is 48, it indicates the end of this study and concludes that biopsy-free radical prostatectomy is feasible.
- If the number of positive cases is 46 or 47, it suggests that the study needs to enter the third phase.
- Implementation of the protocol to completion of phase III
- If the number of positive cases is ≤68, this indicates the end of the study and concludes that radical biopsy-free radical prostatectomy is not feasible.
- If the number of positive cases is ≥69, it indicated the end of the study and concluded that biopsy-free radical prostatectomy is feasible.
- Conditions
- Prostatic Neoplasms, Prostatectomy, Prostate Biopsy
- Keywords
- MRI, PSMA PET/CT, prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The positive rate of pathological diagnosis of prostate cancer
The positive rate of pathological diagnosis of prostate cancer from tissue of prostatectomy for the all the participants.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start10 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
- Investigators
- Dingwei Ye, Doctor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670691
- Sponsor's protocol ID
- FUSCC RP without biopsy
- Status last verified
- Jan 2023
- First submitted
- 18 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not provide IPD sharing to other researchers, but do further analysis in this center.
Publications
Meissner VH, Rauscher I, Schwamborn K, Neumann J, Miller G, Weber W, Gschwend JE, Eiber M, Heck MM. Radical Prostatectomy Without Prior Biopsy Following Multiparametric Magnetic Resonance Imaging and Prostate-specific Membrane Antigen Positron Emission Tomography. Eur Urol. 2022 Aug;82(2):156-160. doi: 10.1016/j.eururo.2021.11.019. Epub 2021 Dec 6.
PubMed 34887117Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28.
PubMed 34465492Chen M, Zhang Q, Zhang C, Zhou YH, Zhao X, Fu Y, Gao J, Zhang B, Wang F, Qiu X, Guo H. Comparison of 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and multi-parametric magnetic resonance imaging (MRI) in the evaluation of tumor extension of primary prostate cancer. Transl Androl Urol. 2020 Apr;9(2):382-390. doi: 10.21037/tau.2020.03.06.
PubMed 32420143Yang FY, Li YJ, Han SJ, Chen D, Wu LY, Xiao ZJ, Li CL, Xing NZ. [The preliminary clinical study on radical prostatectomy without preoperative prostate biopsy]. Zhonghua Yi Xue Za Zhi. 2020 Sep 15;100(34):2658-2662. doi: 10.3760/cma.j.cn112137-20200104-00021. Chinese.
PubMed 32921013Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.
PubMed 28336078Eiber M, Weirich G, Holzapfel K, Souvatzoglou M, Haller B, Rauscher I, Beer AJ, Wester HJ, Gschwend J, Schwaiger M, Maurer T. Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer. Eur Urol. 2016 Nov;70(5):829-836. doi: 10.1016/j.eururo.2015.12.053. Epub 2016 Jan 18.
PubMed 26795686
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Staged, Exploratory Clinical Study of Combined Multiparametric MRI and PSMA PET/CT for the Evaluation of Patients With High Suspicion of Prostate Cancer for Direct Radical Prostatectomy Without Prostate Biopsy
- ClinicalTrials.gov ID
- NCT05670691
- Acronym / sponsor ID
- FUSCC RP without biopsy
- Conditions
- Prostatic Neoplasms, Prostatectomy, Prostate Biopsy
- Keywords
- MRI, PSMA PET/CT, prostate biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 4 Jan 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.
This is an observational, open, single-arm, prospective, staged entry（based on Fleming's Group-Sequential Design） clinical study
The Goal is to evaluate the feasibility and clinical value of direct robot assisted laparoscopic radical prostatectomy without prostate biopsy in patients with high clinical suspicion of prostate cancer based on a prostate MRI PI-RADS score of ≥4 and the PSMA PET/CT positive criteria.
The Primary endpoint is positive pathological diagnosis of prostate cancer after direct radical prostatectomy without prostate biopsy.
The question addressed is whether the feasibility of biopsy-free radical prostatectomy could be scientifically and rationally derived based on Fleming's Group-Sequential design.
Detailed description
Prostate biopsy is currently the key method for diagnosing prostate cancer. However, there are various risks associated with prostate biopsy. First, biopsy complications occur and usually include bleeding, infection, urinary retention, and vasovagal reflexes. Bleeding is one of the most common complications following prostate biopsy, with perineal biopsy hematuria occurring in 39%-44% of cases, rectal bleeding in 17%-27% of cases, and hematospermia in 12%-16% of cases. Infection is one of the more definite complications of prostate biopsy. The incidence is 5-12%. The probability of urinary retention after prostate biopsy is 0.5% to 1.7%. The vasovagal reflex is mainly characterized by a rapid drop in blood pressure, pallor, sweating, nausea, vomiting, chest tightness and, in severe cases, transient coma. The incidence is 0.9% to 16.7%. It is usually necessary to wait 2-4 weeks after biopsy before radical prostate cancer surgery can be performed. Therefore, timely treatment of the patient may be delayed. Second, the pain, anxiety and even fear associated with the biopsy are always with the patient. Third, the issuance of pathology reports generally takes 7-8 days and, if immunohistochemistry is involved, another 2 weeks, a long time with limited management of the full course of the disease, as well as patient attrition.
Multiparametric MRI (mpMRI) has a high tissue resolution and ideal specificity and sensitivity. mpMRI PI-RADS scores of 3, 4 and 5 were associated with a 35%, 60% and 91% diagnosis of prostate cancer, and furthermore, 17%, 34% and 67% diagnosis of CsPCa, respectively.
On the other hand, prostate-specific membrane antigen (PSMA) can specifically anchor prostate cancer cells and has a high sensitivity and specificity for detection.Studies have shown that 68Ga-PSMA PET/CT has a sensitivity of 88%-92% and a specificity of 92%-95% for the diagnosis of prostate cancer. In recent years, PET has also been combined with MRI to obtain many advantages in PET functional imaging as well as MRI imaging discrimination, which is more effective in improving the positive rate of impact diagnosis of prostate cancer.
The combined assessment of multiparametric MRI and PSMA PET/CT has greatly increased the likelihood of prostate cancer in people with multiple abnormalities, and on the other hand, the complications associated with prostate biopsy as well as the delay in surgery and the resulting increased difficulty of surgery. In December 2021, the European Journal of Urology first reported on radical surgery for prostate cancer without biopsy .
The investigators designed this clinical trial based on a combination of multiparametric MRI and PSMA PET/CT to evaluate patients with high suspicion of prostate cancer and make quantitative statistics. mpMRI and PSMA PET/CT were not only among the study parameters, but also could be satisfied with PSMA PET/CT, which was implemented after signing an informed consent after interpretation and performing a direct radical surgery without prostate biopsy.
More importantly, the investigators used Fleming's Group-Sequential Design for the first time, which met the sample size requirements while avoiding the dilemma of having to recruit more patients for the study.
Fleming's Group-Sequential Design
N=71，P0=0.900， P1=0.980 Alpha=0.0230 Power=0.8067
Stage; Sample Size; Cumulative Sample Size; Accept H0 if R ≤ Ag; Reject H0 if R ≥ Rg;
①. 24; 24; 22 27
②. 24; 48; 45 48
③. 23; 71; 68 69
Explanation and description of "Stage Results of Fleming's Group-Sequential Design":
(1) P0=0.900, defined as a pathologically minimum acceptable prostate cancer positivity rate of 90% in the population of patients undergoing biopsy-free radical prostatectomy.
- P1=0.980, defined as a pathologically desirable prostate cancer positivity rate of 98% in the population of patients undergoing biopsy-free radical prostatectomy.
- Based on the Fleming group sequential trial design idea, the sample size is calculated using PASS11 software, with 24 cases in the first stage, 24 cases in the second stage, and 23 cases in the third stage, for a total sample size of 71 cases.
- The protocol is implemented until the completion of the first phase a) If the number of positive cases of pathology after biopsy-free radical prostatectomy is ≤ 22, it indicates the end of this study and concludes that biopsy-free radical prostatectomy is not feasible.
- If the number of positive cases is 23 or 24, then proceed to the second phase.
- The protocol is implemented until the completion of the second phase a) If the number of positive cases is ≤45, it indicates the end of this study and concludes that biopsy-free radical prostatectomy is not feasible.
- If the number of positive cases is 48, it indicates the end of this study and concludes that biopsy-free radical prostatectomy is feasible.
- If the number of positive cases is 46 or 47, it suggests that the study needs to enter the third phase.
- Implementation of the protocol to completion of phase III
- If the number of positive cases is ≤68, this indicates the end of the study and concludes that radical biopsy-free radical prostatectomy is not feasible.
- If the number of positive cases is ≥69, it indicated the end of the study and concluded that biopsy-free radical prostatectomy is feasible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Robotic-assisted laparoscopic radical prostate cancer surgery is recommended for this group of patients. Ultimately, the presence or absence of evidence of malignant prostate cancer on the pathology report after radical prostatectomy is used as an observational endpoint in this study. Relevant perioperative clinicopathological data are also collected according to the study objectives.
Key inclusion criteria (12 listed)
- age ≥ 18 years.
- consent and ability to complete a multiparametric MRI of the prostate.
- consent and ability to complete PSMA PET/CT.
- multiparametric MRI of the prostate with a PI-RADS score of 4 or 5 for suspicious lesions.
- Positive PSMA PET/CT. Its positive is defined as a suspicious lesion score of 2 or 3 (see remarks for specific scoring criteria).
Key exclusion criteria (10 listed)
- unwillingness or inability to perform multiparametric MRI of the prostate; or PI-RADS score of 0-3
- request for prostate puncture biopsy.
- unwillingness or inability to perform PSMA PET/CT; or PSMA PET/CT score of 0 or 1
- refusing radical prostate cancer surgery, or choosing other primary lesion treatment modalities other than radical prostate cancer surgery
- poor physical condition that prevents them from tolerating radical prostate cancer surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The positive rate of pathological diagnosis of prostate cancer
Time frame: two years
The positive rate of pathological diagnosis of prostate cancer from tissue of prostatectomy for the all the participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Results publication: PubMed 34887117Meissner VH, Rauscher I, Schwamborn K, Neumann J, Miller G, Weber W, Gschwend JE, Eiber M, Heck MM. Radical Prostatectomy Without Prior Biopsy Following Multiparametric Magnetic Resonance Imaging and Prostate-specific Membrane Antigen Positron Emission Tomography. Eur Urol. 2022 Aug;82(2):156-160. doi: 10.1016/j.eururo.2021.11.019. Epub 2021 Dec 6.
- Results publication: PubMed 34465492Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28.
- Results publication: PubMed 32420143Chen M, Zhang Q, Zhang C, Zhou YH, Zhao X, Fu Y, Gao J, Zhang B, Wang F, Qiu X, Guo H. Comparison of 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and multi-parametric magnetic resonance imaging (MRI) in the evaluation of tumor extension of primary prostate cancer. Transl Androl Urol. 2020 Apr;9(2):382-390. doi: 10.21037/tau.2020.03.06.
- Results publication: PubMed 32921013Yang FY, Li YJ, Han SJ, Chen D, Wu LY, Xiao ZJ, Li CL, Xing NZ. [The preliminary clinical study on radical prostatectomy without preoperative prostate biopsy]. Zhonghua Yi Xue Za Zhi. 2020 Sep 15;100(34):2658-2662. doi: 10.3760/cma.j.cn112137-20200104-00021. Chinese.
- Results publication: PubMed 28336078Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.
- Results publication: PubMed 26795686Eiber M, Weirich G, Holzapfel K, Souvatzoglou M, Haller B, Rauscher I, Beer AJ, Wester HJ, Gschwend J, Schwaiger M, Maurer T. Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer. Eur Urol. 2016 Nov;70(5):829-836. doi: 10.1016/j.eururo.2015.12.053. Epub 2016 Jan 18.
- Individual participant dataSharing planned: No. The investigators do not provide IPD sharing to other researchers, but do further analysis in this center.
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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.
Dingwei Ye, Doctor study director
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Prostatectomy, run by Fudan 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 10 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 11 Jan 2023. 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 Guowen Lin, doctor (86-021-6175590 ext. 82800, guowenlin@urocancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The positive rate of pathological diagnosis of prostate cancer (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670691, which also lists 6 linked publications.
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 11 Jan 2023.