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New treatment option for Prostatic Neoplasms
Official title Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor
ClinicalTrials.gov ID: NCT05616650
What this study is testing
What is 18F-DCFPyL?
18F-DCFPyL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostatic neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120, men only
You may be able to join if
- Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology...
- Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted...
- Age \>=18 years.
- ECOG performance status \ 60%).
- Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study...
You likely can't join if
- Participants with NCCN high-risk prostate cancer features (Gleason score \>=8, \>cT2c, or PSA \>= 20 ng/mL).
- Participants with prostate biopsies which show \>= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion...
- Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
- Participants who are receiving any other investigational agents.
- Participants found to have pelvic or distant metastases on pre-treatment staging studies.
- Participants with an AUA-SI/IPSS score \> 18.
See the full eligibility criteria
- Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).
- Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.
- Age \>=18 years.
- ECOG performance status \ 60%).
- Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment.
- Ability of individual to understand and the willingness to sign a written informed consent document.
- Participants with NCCN high-risk prostate cancer features (Gleason score \>=8, \>cT2c, or PSA \>= 20 ng/mL).
- Participants with prostate biopsies which show \>= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are...
- Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
- Participants who are receiving any other investigational agents.
- Participants found to have pelvic or distant metastases on pre-treatment staging studies.
- Participants with an AUA-SI/IPSS score \> 18.
- Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.
- Active urinary tract infection assessed by urinalysis.
- Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration...
- Participants with hepatitis B virus (HBV) infection who have not been treated and cured.
- Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.
- Participants with hepatitis C virus (HCV) infection who have not been treated and cured.
- Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.
- Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.
- Participants with connective tissue diseases.
- Participants with radiation hypersensitivity syndromes.
- Ongoing active inflammatory bowel disease within the radiation field.
- Participants with prior medical comorbidity or surgical history involving the low pelvis which is expected to confer a high risk of toxicity to the experimental radiation regimen.
- Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR \ 350 lbs.), a body size unable to fit into the scanner, or implanted devices incompatible with an MRI (implanted...
- Unwillingness to undergo an 18F-DCFPyL PET/CT or known allergy to the 18F-DCFPyL tracer.
- Contraindication or inability to undergo fiducial marker implantation.
- History of prior radiotherapy overlapping with the intended radiation field.
- Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.