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

Launched by M.D. ANDERSON CANCER CENTER · Apr 12, 2024

Keywords

ClinConnect Summary

The PRORAD-5 clinical trial is studying a type of radiation therapy called stereotactic body radiation therapy (SBRT) for patients with advanced prostate cancer. This therapy aims to deliver high doses of radiation precisely to the tumor while minimizing exposure to surrounding healthy tissue. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with advanced prostate cancer and meet certain criteria, such as specific cancer stages and grades.

To be eligible, participants must have a confirmed diagnosis of prostate cancer within the past year, and their cancer must not have spread to distant parts of the body. They should also be able to start the study treatment without any significant health issues that would prevent safe radiation therapy. If you join this trial, you can expect close monitoring by healthcare professionals and possibly receive effective treatment options for your cancer. Overall, this study is important because it may help improve treatment for patients with advanced prostate cancer, offering a new approach that could lead to better outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 1. cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.)
• • 2. Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10).
• • 3. 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).
• • 2. Node negative by conventional imaging.
• • 3. Be ≥ 18 years of age on the day of signing informed consent.
• • 4. 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.
• • 5. ECOG performance status 0-2.
• Exclusion Criteria:
• • 1. Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe RT.
• • 2. Prior prostatectomy, cryosurgery, or HIFU for adenocarcinoma of the prostate
• • 3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
• • 4. Distant metastatic disease on conventional imaging, which by the discretion of the treating physician cannot be treated definitively.