PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI (PRIMARY2)
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|ClinicalTrials.gov Identifier: NCT05154162|
Recruitment Status : Recruiting
First Posted : December 10, 2021
Last Update Posted : April 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Diagnostic Test: PSMA PET/CT Procedure: Transperineal template prostate biopsy Procedure: Transperineal targeted prostate biopsy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multi-centre Randomised Trial of the Additive Diagnostic Value of PSMA PET in Men With Negative/Equivocal MRI in the Diagnosis of Significant Prostate Cancer|
|Actual Study Start Date :||March 2, 2022|
|Estimated Primary Completion Date :||March 2027|
|Estimated Study Completion Date :||March 2028|
Pelvic PSMA PET ± transperineal targeted prostate biopsy
Diagnostic Test: PSMA PET/CT
PSMA PET/CT (limited to the pelvis)
Procedure: Transperineal targeted prostate biopsy
If the PSMA PET/CT is normal, transperineal prostate biopsy would be omitted If the PSMA PET/CT is abnormal, transperineal prostate biopsies would be performed targeting the MRI (done prior to study) and PSMA PET/CT images
No pelvic PSMA PET + transperineal template prostate biopsy
Procedure: Transperineal template prostate biopsy
Transperineal template prostate biopsies will be performed as per treating urologist's usual practice. No specific template for biopsy is prescribed for the purposes of the study. However, template sampling of the prostate is required, with a minimum of 12 cores, dependent on prostate volume. MRI will be available for any additional targeted biopsies required. Transperineal template biopsies must be labelled appropriately and sent for histopathological analysis.
- Presence of sPCa on prostate biopsy [ Time Frame: When histology results are available, at an expected average of 14 days post-biopsy ]sPCa defined as Gleason score 3+4(>10%)=7, Grade group 2 Patients without biopsy (negative PSMA PET) are considered not to have sPCa.
- Number of men who avoid transperineal prostate biopsy in the experimental arm [ Time Frame: When the PSMA PET result is available, at most 28 days after randomisation ]In the experimental arm, if PSMA PET is negative, the patient does not have biopsy
- Presence of insignificant prostate cancer (isPCa) on prostate biopsy [ Time Frame: Within 3 months following randomisation ]isPCa defined as GS 3+3=6, GG 1 or GS 3+4(≤10%)=7, GG 2
- Cost per quality adjusted life year [ Time Frame: Through study completion, estimated up to 2 years ]cost-effectiveness analysis to assess the cost per quality adjusted life year (QALY) gained associated with the use of PSMA PET in addition to MRI compared with MRI alone for the diagnosis of sPCa. Importantly, this analysis will take into consideration the impact on costs and QoL associated with the hypothesised reduction in unnecessary biopsies arising from the improved accuracy of PSMA+MRI and the comparative interventions).
- Health-related quality of life as measured by the EORTC QLQ-C30. [ Time Frame: Within 7 days of randomisation and every 6 months ± 30 days after randomisation ]Quality of life (QoL) will be assessed using QLQ-C30, which contains 30 items across five functional scales, three symptom scales, global health status, and six single items. Participant responses are collected using a four-point response scale ranging from 'Not at all' to "Very much". Higher scores indicate better QoL and function, while high scores for the symptom scale represent a high level of symptoms.
- Anxiety as measured by the GAD7 in the diagnosis of PCa. [ Time Frame: Within 7 days following randomisation and every 6 months ± 30 days after randomisation ]The generalized anxiety disorder Scale (GAD-7)14 is a 7-item, patient-rated questionnaire for screening and severity measuring of generalised anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
- Cancer worry in the diagnosis of PCa. [ Time Frame: Within 7 days following randomisation and every 6 months ± 30 days after randomisation ]The modified Cancer Worry Scale adaptation of Cancer Worry Scale is a 3-item questionnaire used in context of cancer worry in abnormal PSA levels in men participating in community screening program. The score is calculated by assigning scores of 1, 2, 3, and 4, to the categories 'not at all or rarely', 'sometimes', 'often', and 'a lot', respectively, and adding together the scores for the 3 questions. A final question asks about feelings of distress related to cancer risk.
- Number of biopsy cores [ Time Frame: Within 3 months following randomisation ]
Experimental arm: For patients with a positive PSMA PET, the images, the report and a simplified template will be made available to the treating urologist. Up to four identified lesions on PSMA PET and/or MRI will be targeted with each lesion having a minimum 5 cores.
Control arm: Transperineal template prostate biopsies will be performed as per treating urologist's usual practice. No specific template for biopsy is prescribed for the purposes of the study. However, template sampling of the prostate is required, with a minimum of 12 cores,dependent on prostate volume.
- Incidence of complications following transperineal prostate biopsy. [ Time Frame: Within 7 days following randomisation and at 3 and 6 months after randomisation ]Complications following biopsy will be assessed with a modified questionnaire validated in the PRECISION trial. Part 1 following randomisation is a 9 item questionnaire. Part 2 is a 23 item questionnaire administered at 3 and 6 months to assess complications from transperineal prostate biopsy. The following complications will be assessed via these forms: fever, blood in urine, blood in semen, blood in stool, acute urinary retention, erectile dysfunction, urinary incontinence, urinary tract infection and pain in the perineum.
- Incidence of erectile dysfunction following transperineal prostate biopsy [ Time Frame: Within 7 days following randomisation and at 3 and 6 months after randomisation ]The Sexual Health Inventory for Men (SHIM) is an adapted version of the 5 item International Index of Erectile Function (IIEF-5) score, developed to diagnose the presence and severity of erectile dysfunction. This validated questionnaire has a range of scores from 1 to 25, grading erectile dysfunction into 5 categories (none, mild, mild to moderate, moderate and severe).
- Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2) [ Time Frame: Within 28 days following randomisation ]Measured in the experimental arm in patients with positive PSMA PET and negative MRI (PIRADS 2). sPCa defined as Gleason score 3+4(>10%)=7, Grade group 2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05154162
|Contact: Gaurav Sharma||+61 3 8559 6830||Gaurav.Sharma@petermac.org|
|Contact: Annette VanDer Heyden||+61488048792||Annette.VanDerHeyden@petermac.org|
|Principal Investigator:||Michael Hofman||Peter MacCallum Cancer Centre, Australia|
|Principal Investigator:||Louise Emmett||St Vincent's Sydney|