PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer

NCT04220983 | Completed Results DMC FDA Device

• 1 other identifier: 19-04020263
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Number of Subjects With Adverse Events Will be Collected

  Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment.

  baseline, 3-6months and at 9-12 months.

Secondary Outcomes (2)

• Change in Quality of Life Questionnaires Will be Assessed.

  baseline, 3-6months and at 9-12 months.

• Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.

  baseline, 3-6months and at 9-12 months.

Study Arms (1)

MR-Guided Prostate SBRT

OTHER

Radiation: MR-Guided Prostate SBRT

Interventions

MR-Guided Prostate SBRT RADIATION

Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity when planning is delivered appropriately.

MR-Guided Prostate SBRT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven diagnosis of prostate adenocarcinoma
• Age ≥ 18
• Must have biopsy-proven metastatic prostate cancer

You may not qualify if:

• History of prior pelvic radiation (external beam or brachytherapy)
• Inability to undergo MRI
• AUA score \>20
• For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sharanya Chandrasekhar
• Organization: Weill Cornell Medicine

shc2043@med.cornell.edu

646-962-3110

Study Officials

• Silvia Formenti, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 7, 2020
• Study Start: January 27, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)