RecruitingNot applicable

PSMA PET for Surveillance After Focal Therapy

Prospective Evaluation of PSMA PET Imaging in Surveillance Post-Focal Therapy for Prostate Cancer (PSMA-FT Surveillance Study)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
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

  • Time periods mentioned: 12 months
  • Procedures mentioned: MRI scans, PET scans, Biopsies

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
  • "This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer."
  • "A PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate."
  • "An mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate."
  • "Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate."
  • "Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans."
  • "People who agree to join the study will be asked to attend study visits for about 12 months after focal therapy."
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 routine MRI scans helps find prostate cancer that comes back after focal therapy. Focal therapy treats only part of the prostate. The study is for adult men who plan to have this treatment.

This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. PSMA PET and multiparametric (mpMRI are both imaging tests that help detect prostate cancer in the body. A PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate. An mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate. Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate. Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans. This study will be funded by Blue Earth Diagnostics, a molecular imaging company based in England.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must be assigned male at birth and at least 18 years old.
  • Must understand the study and give written consent.
  • Must have prostate cancer confirmed by both a 12-sample biopsy and a targeted biopsy within 1 year before consent. A biopsy takes small tissue samples to check for cancer.
  • Must choose focal therapy and be scheduled to have it within 6 months after consent.
  • Cancer must not have spread to distant parts of the body. For higher-risk cancer, scans must confirm this within 6 months before joining.
  • Must meet the study’s rating for ability to do daily tasks: ECOG of 2 or less, or Karnofsky score of at least 60%.
  • Must be fit for surgery and medicine that puts you to sleep. The surgeon must be able to see and reach the prostate and nearby areas, and you must tolerate the needed position.
  • No more than half of participants may have favorable intermediate-risk cancer, a lower-risk type within the middle-risk group.

Who can't join

  • Had prostate cancer treatment within the past 12 months. Prior radiation or hormone-lowering treatment is allowed if given more than 12 months before the cancer was found to have returned.
  • Cancer has grown into nearby areas, reached lymph nodes, or spread to distant parts of the body.
  • Cannot safely have a pelvic MRI, such as because of severe fear of tight spaces, a permanent pacemaker, metal implants that blur images, or an allergy or other reason to avoid the MRI dye.
  • Have another illness that is not controlled or causes major limits in daily life.
  • The study doctor thinks participation is not suitable and you are unlikely to follow the study’s steps and rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Subjects must be male (assigned male at birth) and 18 years or older. 2. Subjects must demonstrate the ability to understand and provide written informed consent. 3. Subjects must have histologically confirmed prostate cancer ( PCa) Note: Recruitment will be limited to a maximum of 50% of subjects with favorable intermediate-risk prostate cancer (PCa) Note: The histopathologic diagnosis must be obtained via "Prostate Biopsy (PB)", which for the purposes of the present study, is defined as both a systematic 12-core sextant random prostate biopsy and a targeted prostate biopsy. The targeted prostate biopsy can be performed via in-bore multiparemetric (mp) magnetic resonance imaging (MRI) prostate biopsy, cognitive mpMRI/ultrasound fusion prostate biopsy or software mpMRI/ultrasound fusion prostate biopsy. This "PB" must not be obtained greater than 1 year from the date of consent. 4. Subjects must have chosen to get focal therapy (partial gland ablation) for the treatment of prostate cancer and must be scheduled for partial gland ablation/focal therapy with any energy modality within 6 months following informed consent. 5. Subjects must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk and high risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and technetium-99-mDP nuclear medicine bone scan (BS) and/or PSMA-PET imaging prior to enrollment. The imaging studies should be obtained within 6-months of enrollment. 6. Subjects must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, (see Appendix A). 7. Subjects must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum, as well as be tolerant of lithotomy positioning in the opinion of the treating investigator or the operating surgeon(s) if not the same as the treating investigator. Exclusion Criteria: 1. Subject had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa within last 12 months. Subjects who received radiation and/or androgen deprivation therapy for prostate cancer more than 12 months prior to diagnosis of recurrent prostate cancer will be eligible for the trial. 2. Subjects with locally advanced, nodal or metastatic prostate cancer. 3. Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia), permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent. 4. If the subject has an uncontrolled or major debilitating inter-current illness. 5. Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.

Study sites (1)

IL