Recruiting
Phase 2

MR-LINAC

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04402151

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC

Stereotactic Body Radiation Therapy (SBRT)

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT04402151

Start date

Jun 30, 2020

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single Arm

Patients enrolling on the protocol will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR) prior to start of the radiation treatment planning process. PSMA tracer is administered by IV injection and PET images are acquired.

Any patients found to have possible metastatic disease will undergo a standard of care confirmatory biopsy (if feasible) and receive treatment appropriate for their stage.

The PSMA PET/MR scan will be performed prior to initiation of androgen deprivation therapy (ADT).

Interventions

PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC

Patients enrolling on the protocol will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR) prior to start of the radiation treatment planning process. PSMA tracer is administered by IV injection and PET images are acquired.

Any patients found to have possible metastatic disease will undergo a standard of care confirmatory biopsy (if feasible) and receive treatment appropriate for their stage.

The PSMA PET/MR scan will be performed prior to initiation of androgen deprivation therapy (ADT).

Stereotactic Body Radiation Therapy (SBRT)

Patients will receive standard of care radiation therapy (SBRT)

Primary outcome measure

  • Clinical efficacy of prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR), MR-Linear Accelerator (LINAC) will be assessed by evaluating recurrence free survival [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Fabiana Gregucci, M.D.

646-962-3110fgr4002@med.cornell.edu

Dakota Trick

646-962-3118dat4015@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065'

Contacts

Fabiana Gregucci, M.D.

646-962-3110fgr4002@med.cornell.edu

Dakota Trick

646-962-3118dat4015@med.cornell.edu

Principal Investigator:

Silvia Formenti, M.D.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-01-26.