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

NCT04402151 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: 19-10020928R01CA249615
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  Evaluate the clinical efficacy of PSMA PET/MR guided, MR-LINAC-based SBRT- SIB in high-intermediate and high risk prostate cancer, as evaluated by the 2-year recurrence-free survival rate

  24 months

Secondary Outcomes (14)

• Performance of PSMA PET/MR to MR alone at staging prostate cancer

  Baseline

• Performance of PSMA PET/MR to MR alone for identification of dominant intraprostatic nodules during radiation planning

  Baseline

• Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA

  Baseline

• Compare imaging biomarkers of interest on MR and PSMA PET/MR as predictors of treatment response, versus biopsy of treatment response and PSA

  12 months

• Change in Quality of life questionnaires (EPIC-26) will be assessed.

  Baseline, 1month, 6months, 12 months, 18 months and 24 months.

Study Arms (1)

Single Arm

OTHER

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).

Drug: PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC; Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Patients will receive standard of care radiation therapy (SBRT)

Single Arm

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

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).

Single Arm

Eligibility Criteria

• Age: 21 Years - 90 Years
• Gender Eligibility Details: Male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator
• Telix Pharmaceuticals: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065', United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Silvia Formenti, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Gregucci, M.D.

CONTACT

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

Dakota Trick

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 26, 2020
• Study Start: June 30, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)