PSMA-PET to Guide Prostatectomy
PSMA-PET to Guide Prostatectomy: A Randomized Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 80 Years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "PET (and MRI) findings will be validated against whole mount pathology."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding a PSMA PET scan to the usual MRI scan before prostate cancer surgery helps guide surgery plans and affects patient results. It is for people with prostate cancer who plan to have their prostate removed and want to keep their ability to have erections. The 196 patients will be assigned by chance to MRI alone or MRI plus PSMA PET.
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have prostate cancer that meets the study’s rules for Gleason score (a cancer grade), amount of cancer in biopsy samples, or cancer risk level.
- Have no trouble getting or keeping erections, or only mild to moderate trouble, based on a sexual function survey.
- Want to keep the ability to have erections after treatment.
- Plan to have an MRI, or have had one within 6 months before surgery. If the MRI is too old or does not use the required scanner strength, the study will repeat it at IU ORI at no cost to you.
- Your treating cancer doctor considers you a candidate for prostate removal surgery, with surgery planned within 90 days after you agree to join.
Who can't join
- Are in another research study that exposes you to ionizing radiation, or took part in one within the past 30 days.
- Cannot safely have an MRI, such as because of a metal implant that is not allowed.
- Have a major short-term or long-term illness that the study doctor believes could make the study unsafe, keep you from finishing it, or interfere with its goals.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR NCCN unfavorable intermediate risk OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND 2. Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND 3. The patient desires to maintain erections following treatment 4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant. 5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent. Exclusion Criteria: 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison). 3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Study sites (1)
IN
- Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine · Indianapolis, IN 46202Mark Green, Ph.D · Study contactMore trials in Indianapolis