Prostate Cancer Clinical Trial
— IP7-PACIFICOfficial title:
Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer
To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer. To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk. To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.
Status | Not yet recruiting |
Enrollment | 3600 |
Est. completion date | January 31, 2026 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Randomisation 1 Inclusion Criteria: - Age 18 years or above (no upper limit) - Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all). - Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and/or an elevated PSA (within 6 months of screening visit) PSA >/=3.0ng/ml for age 50-69 years PSA >/=5.0ng/ml for age >/=70 years If family or ethnic risk for prostate cancer, PSA >/=2.5ng/ml for age 45-49 years Exclusion Criteria: - PSA >50ng/ml - Prior prostate MRI or prostate biopsy in the two years prior to screening visit - Prior diagnosis of prostate cancer - Contraindication to MRI or gadolinium contrast - Previous hip replacement to both hips - Contraindication to performing a biopsy guided by a transrectal ultrasound probe Randomisation 2 Inclusion Criteria: - Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema) Exclusion Criteria: - As above for randomisation 1 - Patient refusal for biopsy |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Imperial College London | Cancer Research UK, National Institute for Health Research, United Kingdom |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Randomisation 1: Proportion of clinically significant cancers detected in the randomised population of patients at risk. | Proportion of clinically significant cancers, defined as any amount of Gleason =3+4 (ISUP Grade Group =2) on biopsy, detected in the randomised population of patients at risk. | maximum 12 weeks following enrolment | |
Primary | Randomisation 2: Proportion of clinically significant cancers detected in the randomised population of patients biopsied for a suspicious MRI. | Proportion of clinically significant cancers, defined as any amount of Gleason =3+4 (ISUP Grade Group =2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI. | maximum 12 weeks following enrolment | |
Secondary | MRI related adverse events | MRI related adverse events measured using documentation | maximum 12 weeks following enrolment | |
Secondary | MRI related serious adverse events | MRI related serious adverse events measured using documentation | maximum 12 weeks following enrolment | |
Secondary | Biopsy related adverse events | biopsy-related adverse events measured using documentation | maximum 12 weeks following enrolment | |
Secondary | Biopsy related serious adverse events | biopsy-related serious adverse events measured using documentation | maximum 12 weeks following enrolment | |
Secondary | The proportion of patients advised to undergo a needle biopsy after MRI | The proportion of patients advised to undergo a needle biopsy. The researchers will document common reasons for patients who are advised to undergo a biopsy or advised against a needle biopsy and still choose to have a biopsy. | maximum 12 weeks following enrolment | |
Secondary | The proportion of patients advised to undergo a prostrate biopsy after MRI | The proportion of patients undergoing a prostate biopsy after MRI. The researchers will document common reasons for patients who are advised to undergo prostrate biopsy after MRI. | maximum 12 weeks following enrolment | |
Secondary | The proportion of patients diagnosed with clinically significant prostates cancers on needle biopsy | The proportion of patients diagnosed with clinically significant prostates cancers defined as any Gleason 3+3=6 on needle biopsy carried out after MRI. | maximum 12 weeks following enrolment | |
Secondary | The proportion of patients diagnosed with clinically significant prostate cancers on prostate biopsy carried out after MRI | The proportion of patients diagnosed with clinically significant prostate cancers using other histological thresholds on prostate biopsy carried out after MRI.
The researchers will evaluate these proportions by MRI score at patient and lesion level (on a scale of 1 to 5) and by the presence or absence of clinical risk parameters. |
maximum 12 weeks following enrolment | |
Secondary | The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using four targeted cores | The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using four targeted cores | maximum 12 weeks following enrolment | |
Secondary | The proportion of patients diagnosed with clinically significant prostate cancers with targeted biopsy using six targeted cores | The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using six targeted cores | maximum 12 weeks following enrolment | |
Secondary | Detection rates for each randomised group of known prognostic risk categories | Detection rates for each randomised group of known prognostic risk categories. These are D' Amico, National Comprehensive Cancer Network (NCCN) and Cambridge Prognostic Groups (CPG). | maximum 12 weeks following enrolment | |
Secondary | Use Likert MRI scoring system to analyse the proportion of patients biopsied | A comparison of the two MRI scoring systems, Likert and PIRADS (the latest version as defined in MRI Reporting SOP), in terms of the proportion of patients biopsied and subsequently diagnosed with clinically significant and clinically insignificant prostate cancer, using each of the histological thresholds, on a prostate biopsy. | maximum 12 weeks following enrolment | |
Secondary | Use Prostate Imaging Reporting and Data System (PIRADS) MRI scoring system to analyse the proportion of patients biopsied | A comparison of the two MRI scoring systems, Likert and PIRADS (the latest version as defined in MRI Reporting SOP), in terms of the proportion of patients biopsied and subsequently diagnosed with clinically significant and clinically insignificant prostate cancer, using each of the histological thresholds, on a prostate biopsy. | maximum 12 weeks following enrolment | |
Secondary | Characteristics of cancer in targeted systematic biopsies | Characteristics of cancer in targeted versus systematic biopsies by MRI score, PSA, PSA density, age, ethnicity, family history and history of prior prostate biopsy with a multivariable evaluation to determine whether patients might avoid systematic sampling in the future. | maximum 12 weeks following enrolment | |
Secondary | Characteristics of cancer in targeted biopsies | Characteristics of cancer in targeted versus systematic biopsies by MRI score, PSA, PSA density, age, ethnicity, family history and history of prior prostate biopsy with a multivariable evaluation to determine whether patients might avoid systematic sampling in the future. | maximum 12 weeks following enrolment | |
Secondary | External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score (MRI+) | External validation of the Imperial RAPID Risk Score (MRI+) within each randomised group of the IP7-PACIFIC study, external validation | maximum 12 weeks following enrolment | |
Secondary | External validation of the Imperial Rapid Access to Prostate Imaging and Diagnosis (RAPID) Risk Score in (Systematic+) | External validation of Imperial Rapid Access to Prostate Imaging and Diagnosis(RAPID) Risk Score (Systematic+) within each randomised group of the IP7-PACIFIC study, external validation | maximum 12 weeks following enrolment | |
Secondary | Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported outcomes | Impact of prostate biopsy in each randomised group on patient-reported outcomes using a survey that includes EQ-5D-5L health-related quality of life questionnaire | maximum 12 weeks following enrolment | |
Secondary | Impact of prostate biopsy in second randomised group (mpMRI)on patient-reported outcomes | Impact of prostate biopsy in each randomised group on patient-reported outcomes using a survey that includes EQ-5D-5L health-related quality of life questionnaire | maximum 12 weeks following enrolment | |
Secondary | Impact of prostate biopsy in first randomised group (bpMRI) on patient-reported experience measures | Impact of prostate biopsy in each randomised group on patient-reported experience measures using version of the Prospective cohort study (Prostate Biopsy Effects: ProBE) questionnaire. | maximum 12 weeks following enrolment | |
Secondary | Impact of prostate biopsy in second randomised group (mpMRI) on patient-reported experience measures | Impact of prostate biopsy in each randomised group on patient-reported experience measures using version of the Prospective cohort study (Prostate Biopsy Effects: ProBE) questionnaire. | maximum 12 weeks following enrolment | |
Secondary | Analysis of biopsy rate in cancer detection (by all histological thresholds) during the time of study | Analysis of biopsy rates in cancer detection (by all histological thresholds) in the randomised group will be conducted by centre using centre size.
MRI scanner type (1.5 Tesla vs. 3.0 Tesla), type of biopsy route used (transrectal vs trans perineal), number of systematic biopsies taken (limited systematic vs extended systematic biopsy), type of analgesia/anaesthetic (local anaesthetic, sedation or general anaesthetic) as additional stratification factors |
maximum 12 weeks following enrolment |
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