Five Fraction Radiotherapy for Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, and/or ≥ 50% biopsy cores positive, and/or 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 it's running

• 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
• Email: cjhassanzadeh@mdanderson.org
• Phone: (713) 657-9802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.