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RecruitingPhase 2

Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk Prostate Cancer

Single-Arm Phase II Study of PSMA PET/MR Guided Stereotactic Body Radiation Therapy With Simultaneous Integrated Boost (SBRT-SIB) for High-Intermediate and High Risk 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
21 Years to 90 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

Not stated in the study description — ask the study team about visits and procedures.

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 focused radiation treatment guided by PSMA PET/MR scans, which help locate prostate cancer. It gives an extra radiation dose to targeted areas. It is for men age 21 or older with higher-risk prostate cancer that has not spread.

This is a single-arm Phase II clinical trial assessing the clinical efficacy of prostate specific membrane antigen (PSMA) PET/MR guided MR-LINAC based SBRT-SIB with planned accrual of 50 patients.

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

Eligibility

Who can join

  • You are a man age 21 or older.
  • You can sign a consent form and are willing to follow the study rules.
  • A tissue test confirms prostate adenocarcinoma, a type of prostate cancer.
  • Your cancer meets the study's high-risk or unfavorable intermediate-risk rules. These use the cancer's grade, PSA blood test level, size or extent, and the amount of cancer in biopsy samples.
  • If sexually active, you agree to use approved birth control and condoms for 7 days after each PSMA injection.
  • There is no sign that cancer has spread, including to lymph nodes in the pelvis.

Who can't join

  • You have health or technical issues that would prevent proper analysis of the PET or MR scans.
  • You cannot safely receive a PSMA injection into a vein.
  • You have had surgery through the urine tube to remove prostate tissue.
  • Your prostate is larger than 150 cubic centimeters.
  • Your AUA score, which measures urinary symptoms, is above 20.
  • You have had radiation to the prostate before.
  • The study team decides you are not suitable for the study for another reason.
  • You take or plan to take abiraterone.

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

Official eligibility criteria

Inclusion Criteria: * Male aged 21 years or older. * Ability to provide signed informed consent and willingness to comply with protocol requirements. * Pathologic confirmation of high-risk adenocarcinoma of the prostate gland as follows: a. Gleason 8-10 or tertiary component 5 disease and/or b. PSA of 20 ng/ml or greater and/or c. Tumor stage of T2c or greater; OR Unfavorable intermediate risk (Gleason 4+3=7, \>50% of cores involved, or 2 or more intermediate risk factors which include Gleason 7 disease, PSA 10-20, or T2b disease) * Participants must agree to use an acceptable form of birth control and utilize condoms for a period of seven days after each PSMA injection, if engaged in sexual activity. * No evidence of metastatic disease, including pelvic lymph nodes. Exclusion Criteria: * Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MR. * Contraindications to PSMA IV administration * Contraindications to prostate SBRT (history of transurethral resection of prostate; prostate size greater than 150 cc; AUA score greater than 20; history of prior radiation to the prostate) * Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment * Patients on or intending to take abiraterone will be excluded

Study sites (1)

NY