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RecruitingEarly Phase 1

Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT

Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT and Dynamic Dosimetry With Registered Ultrasound and Fluoroscopy for Localized Prostate Cancer

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 to 100 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, CT scans, Ultrasound

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
  • "Current conventional prostate cancer (PCa) imaging modalities (computed tomography, bone scan, magnetic resonance imaging, ultrasound) have limited accuracy in the initial staging and for determining prognosis of PCa."
  • "Combined PET and computed tomography (PET-CT) imaging using small molecules targeting PSMA-expressing cells have been developed and tested clinically, and have shown superiority when compared with conventional imaging."
  • "An added advantage of PET compared to MRI is the ability to identify both distant metastatic disease as well as intraprostatic disease with one imaging modality."
  • "This highlights the key utility and importance of the investigators' iRUF system (integrated Registered Fluoroscopy and Ultrasound) in delivering focal therapy."
  • "The investigators have developed a system of true dynamic intraoperative dosimetry which utilizes fluoroscopy for seed cloud reconstruction and fusion to transrectal ultrasound imaging."
  • "The investigators confirmed the primary endpoint to compare intraoperative dosimetric predicted values using iRUF method vs standard ultrasound-based seed tracking."
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 using special scans and biopsy results to guide brachytherapy, a treatment that places radiation sources inside the prostate. It is for people with prostate cancer who will have this treatment. Areas without important cancer will not be directly targeted but will still receive some nearby radiation, with the aim of reducing side effects.

The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. In the PI's clinical trial, the uninvolved regions (as defined by combined PET-MR-biopsy data) will not be targeted and receive only fall-off dose, which we have shown to be associated with reductions in toxicity.

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 adenocarcinoma, a type of prostate cancer.
  • Are fully active or can do light work despite some limits on physical activity.
  • Have clinical stage T1c–T2a cancer, based on the clinical exam; lymph node involvement and distant spread must be absent or unknown.
  • Have a Gleason score of 6–7, a measure of how abnormal the cancer cells look.
  • Have a prostate smaller than 60 cc; the MRI measurement is used if scan measurements differ.
  • Have a urinary symptom score (IPSS) of 20 or less.
  • Can have a DCF-Pyl PSMA PET scan, a special scan used to check the cancer before treatment.
  • Sign the study consent form before joining.

Who can't join

  • Have had radiation treatment to the pelvic area.
  • Have a major medical or mental health condition that the study doctor thinks would prevent finishing treatment or follow-up visits.
  • Have an implanted device that blocks the view of radiation sources on live X-ray images.
  • Cannot have an MRI because of metal implants or another medical reason, or have fear of enclosed spaces that medicine cannot help.
  • Have had another cancer diagnosed within the past 3 years.

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

Official eligibility criteria

Inclusion Criteria: * Adenocarcinoma of the prostate * Performance Status \< 2 * Clinical stages (not radiographic stage) T1c - T2a, Nx or N0, Mx or M0 * Gleason 6-7 cancer * Prostate volume \< 60 cc (if MRI and TRUS have conflicting values, then MRI value will be utilized) * International Prostate symptom score (IPSS) 20 or less * Ability to undergo DCF-Pyl PSMA PET as part of pretreatment staging * Signed study-specific consent form prior to registration Exclusion Criteria: * Prior history of pelvic radiation therapy * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. * Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy * Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing MR scanning * History of other malignancy diagnosed within the past 3 years

Study sites (1)

MD