RecruitingPhase 1NCT06369246
PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.
Sponsor
M.D. Anderson Cancer Center
Enrollment
70 participants
Start Date
Jun 27, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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.
Exclusion Criteria4
- 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.
Interventions
DEVICEStereotactic Body Radiation Therapy
Undergo Radiation Therapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06369246
Related Trials
Engage Psychosocial Intervention for Cancer Symptoms
NCT065555881 location
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
NCT0580066525 locations
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
NCT060950896 locations
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
NCT063359141 location
Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer
NCT071154461 location