PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy

Treatment groups

70 Participants
are divided into 1 treatment group

Sponsors and collaborators