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

Last updated: January 28, 2026
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

Stereotactic Body Radiation Therapy

Clinical Study ID

NCT06369246
2023-0893
NCI-2024-03308
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinomaof prostate within one year of study entry. Evaluation can happen outside of MDAnderson as long as histological confirmation takes place at MD Anderson.

  2. cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital examor imaging (AJCC 8th Ed.)

  3. Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10).

  4. If Gleason Grade 2, must meet definition of unfavorable intermediate risk (atleast one of the following: cT2b, PSA >10 ng/mL prior to starting androgendeprivation therapy (ADT). If a participant is taking 5-alpha reductase inhibitors the measured PSA may bedoubled).

  5. Node negative by conventional imaging.

  6. Be ≥ 18 years of age on the day of signing informed consent.

  7. Prior pharmacologic androgen ablation for prostate cancer is allowed only if theonset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 daysprior to registration; Please note: baseline PSA must be obtained prior to the startof any ADT.

  8. ECOG performance status 0-2.

Exclusion

Exclusion Criteria:

  1. Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in theopinion 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 ofradiation fields

  4. Distant metastatic disease on conventional imaging, which by the discretion of thetreating physician cannot be treated definitively.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Stereotactic Body Radiation Therapy
Phase: 1
Study Start date:
June 27, 2024
Estimated Completion Date:
September 01, 2027

Study Description

Primary Objectives:

Primary Objective #1: To determine the proportion of patients experiencing late grade ≥ 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment.

Primary Objective #2: To estimate the change in health-related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT. Patient-reported urinary, bowel, and sexual function and general QoL will be collected using validated EPIC-26, EQ-5D, PROMIS-Fatigue questionnaires prior to RT, at the end of RT 3, and 6, 12, 24 months after completion of RT.

Secondary Objectives:

Secondary Objective #1: To estimate the metastasis free survival (MFS) at 24 months after study enrollment. All time-to-event analyses will be analyzed indexed to date of study enrollment.

Secondary Objective #2: To estimate the rate of acute and late GI and GU toxicity of the treatment regimen

Secondary Objective #3: To assess adherence to protocol treatment parameters. RT plans will be evaluated for contouring consistency, target coverage and tissue constraint adherence with the use of artificial intelligence (AI) auto-segmentation/contours and scorecards to facilitate this process and improve plan quality and clinical efficiency.

Secondary Objective #4: To explore the impact of five fraction pelvic nodal RT on lymphopenia.

White blood cell counts will be obtained before and after treatment and compared to historical data on lymphopenia with conventionally fractionated pelvic RT.

Secondary Objective #5: To estimate HRQOL following the proposed treatment regimen compared to pre-treatment assessment at the end of RT 3 months, 12, and 24 months after completing RT and assess the HRQOL change over time.

Exploratory Objective #1: To investigate the effect of pelvic nodal RT on gut microbiome with gut microbiome sample collection pre- and upon RT completion.

Connect with a study center

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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