Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging. (NCT03465579) | Clinical Trial Compass
TerminatedNot Applicable
Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.
Stopped: Patients in cohort 1 continued for prolonged periods given the difficulties encountered in the COVID period and to date in this setting evidence has already developed that reduces the the innovativeness of the project.
Italy261 participantsStarted 2018-05-23
Plain-language summary
BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI) and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically-proven adenocarcinoma of the prostate;
. Age ≥ 18
. Men should be fit for curative treatment;
. Clinical stage T1c or T2;
. Gleason score 3+3=6;
. One or two biopsy cores invaded with prostate cancer:
. If an MRI, including targeted biopsies on positive lesions, is done at inclusion, there is no limit in the number of positive cores (that is, more than two, and no limit in the % of cancer present in the cores);
. If saturation biopsies (either trans-perineal or trans-rectal) are done 15% of the cores can be positive with a maximum of 4 (i.e. 26 cores 4 cores can be positive) (all other inclusion criteria still apply);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
2
specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
3
Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
4
negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Timeframe: up to 36 months
Trial details
NCT IDNCT03465579
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
. Hormone androgen deprivation therapy of any type within 6 months prior to enrollment.
. Prior pelvic radiotherapy;
. Sickle cell disease;
. Insufficient renal function (eGFR \< 30 mL/min/1.73 m2);
. Hip prosthesis, vascular grafting or other conditions affecting imaging;
. Contraindication to MRI, including but not restricted to: pacemaker or other electronic im-plants, known metal in the orbit, MR incompatible surgical or cerebral aneurysm clips, shrapnel, tattoos, non-removable body piercings (relative contraindications);
. History of allergic reactions attributed to compounds of similar chemical or biologic com-position to 68Ga-PSMA or Gadolinium-based contrast agents used in the study.