Five Fraction Radiotherapy for Advanced Prostate Cancer

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

This study is testing a new type of radiation therapy for men with advanced prostate cancer to see how safe it is and how it affects their quality of life and side effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06369246 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of stereotactic body radiation therapy (SBRT) for patients with advanced or high-risk prostate cancer. It aims to determine the incidence of late gastrointestinal toxicity and assess changes in health-related quality of life following treatment. The study will also analyze metastasis-free survival and the impact of treatment on lymphopenia, utilizing advanced AI techniques for treatment planning. Patient-reported outcomes will be collected at multiple time points to gauge the treatment's effects on urinary, bowel, and sexual function.

Who should consider this trial

Good fit: Ideal candidates include adult males with a confirmed diagnosis of advanced prostate cancer who meet specific clinical criteria regarding tumor stage and Gleason score.

Not a fit: Patients with prostate cancer that is classified as cT3b-4 or those with node-positive disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective radiation therapy option for patients with advanced prostate cancer.

How similar studies have performed: Previous studies have shown promising results with stereotactic body radiation therapy in similar patient populations, indicating potential for success in this approach.

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.

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Comron Hassanzadeh, MD — M.D. Anderson Cancer Center
• Study coordinator: Comron Hassanzadeh, MD

Conditions Advanced Prostate Cancer