NCT06369246

Brief Summary

To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
16mo left

Started Jun 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2024Sep 2027

First Submitted

Initial submission to the registry

April 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 27, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

April 12, 2024

Last Update Submit

March 5, 2026

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (1)

Stereotactic Body Radiation Therapy

EXPERIMENTAL

Participants will then be scheduled to receive radiation therapy. Radiation will be given over 5 sessions, 2-3 times per week, for 2 weeks. Each radiation therapy session will take 15-30 minutes to complete. Within 1 day after completing radiation therapy, blood (about 2 tablespoons) will be drawn for routine tests.

Device: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation TherapyDEVICE

Undergo Radiation Therapy

Stereotactic Body Radiation Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson.
  • cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.)
  • Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10).
  • If Gleason Grade 2, must meet definition of unfavorable intermediate risk (at least one of the following: cT2b, PSA \>10 ng/mL prior to starting androgen deprivation therapy (ADT).
  • If a participant is taking 5-alpha reductase inhibitors the measured PSA may be doubled).
  • Node negative by conventional imaging.
  • Be ≥ 18 years of age on the day of signing informed consent.
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT.
  • ECOG performance status 0-2.

You may not qualify if:

  • Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe RT.
  • Prior prostatectomy, cryosurgery, or HIFU for adenocarcinoma of the prostate
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
  • Distant metastatic disease on conventional imaging, which by the discretion of the treating physician cannot be treated definitively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Comron Hassanzadeh, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Comron Hassanzadeh, MD

CONTACT

(713) 657-9802cjhassanzadeh@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 16, 2024

Study Start

June 27, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 9, 2026

Record last verified: 2026-01

Locations

US(1)