Clinical trial NCT05154162: PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
PSMA PET
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
Collaborators: name: St Vincent's Hospital, Sydney
First posted: 2021-12-10
Enrollment: 660
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI

Detailed description: This open label, phase III, multi-centre, randomised trial with a non-inferiority objective will evaluate the additive diagnostic value of PSMA PET for men with negative/equivocal MRI in the diagnosis of significant prostate cancer. Patients with a clinical suspicion of prostate cancer with PI-RADS 2 or 3 on MRI, meeting all the inclusion and none of the exclusion criteria will be randomised into experimental and control arms. Patients in the experimental arm would be subjected to Pelvic PSMA PET/CT, wherein the PSMA negative patients would not undergo biopsy as opposed to PSMA positive patients who will be subjected to Transperineal targeted prostate biopsy. Whereas patients in the control arm will only receive Standard of Care (SOC) with no additional imaging (PSMA PET) and will undergo Transperineal template prostate biopsy. The co-primary objectives are to assess (1) the percentage of men with sPCa in the experimental arm (transperineal targeted biopsy) compared to the control arm (transperineal template biopsy) defined as the presence of a single biopsy core indicating disease Gleason score (GS) 3+4(\>10%)=7, grade group (GG) 2, and (2) the percentage of men who avoid transperineal prostate biopsy between both arms. The secondary objectives include determining the percentage of clinically insignificant PCa on targeted biopsy (experimental arm) versus transperineal template biopsy (control arm); estimating the difference in complications from transperineal prostate biopsy between both arms; the health economics impact between the experimental and control arms; estimating the mean difference between both arms in change from baseline in health-related quality of life (QoL); estimating the mean difference between both arms at each time point in generalised anxiety and cancer worry.

Eligibility criteria: Inclusion Criteria:

* Patients must meet all the following criteria for study entry:

  1. Males aged ≥ 18 years at the time of consent
  2. No previously diagnosed prostate cancer
  3. No previous prostate biopsy
  4. Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria:

     * PI-RADS 2 AND ≥1 red flag defined as:

       * PSA density \>0.1
       * Abnormal DRE
       * Strong family history (1 first degree relative or ≥2 second degree)
       * BRCA mutation
       * PSA \>10
       * PSA doubling time \<36 months
       * PSA velocity \>0.75/year
     * PI-RADS 3
  5. Intention for prostate biopsy
  6. Willing and able to comply with all study requirements

Exclusion Criteria:

* Patients who meet any of the following criteria will be excluded from study entry:

  1. Having a PSA \>20ng/ml
  2. Having ≥ cT3 on DRE
  3. Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol

Primary outcomes:
measure: Presence of sPCa on prostate biopsy
timeFrame: When histology results are available, at an expected average of 14 days post-biopsy
measure: Number of men who avoid transperineal prostate biopsy in the experimental arm
timeFrame: When the PSMA PET result is available, at most 28 days after randomisation
Secondary outcomes:
measure: Presence of insignificant prostate cancer (isPCa) on prostate biopsy
timeFrame: Within 3 months following randomisation
measure: Cost per quality adjusted life year
timeFrame: Through study completion, estimated up to 2 years
measure: Health-related quality of life as measured by the EORTC QLQ-C30.
timeFrame: Within 7 days of randomisation and every 6 months ± 30 days after randomisation
measure: Anxiety as measured by the GAD7 in the diagnosis of PCa.
timeFrame: Within 7 days following randomisation and every 6 months ± 30 days after randomisation
measure: Cancer worry in the diagnosis of PCa.
timeFrame: Within 7 days following randomisation and every 6 months ± 30 days after randomisation
measure: Number of biopsy cores
timeFrame: Within 3 months following randomisation
measure: Incidence of complications following transperineal prostate biopsy.
timeFrame: Within 7 days following randomisation and at 3 and 6 months after randomisation
measure: Incidence of erectile dysfunction following transperineal prostate biopsy
timeFrame: Within 7 days following randomisation and at 3 and 6 months after randomisation
measure: Number of men who have sPCa detected only with PSMA PET (MRI PI-RADS 2)
timeFrame: Within 28 days following randomisation
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Cabrini Health
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Michael Hofman
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Sydney
name: Louise Emmett
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabrini Health
name: Mark Frydenberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Health
name: Sze-Ting Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brisbane and Women's Hospital
name: Matthew Roberts
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Adelaide Hospital
name: Yang Du
role: PRINCIPAL_INVESTIGATOR
References: