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Trial Title:
PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer
NCT ID:
NCT06369246
Condition:
Advanced Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo Radiation Therapy
Arm group label:
Stereotactic Body Radiation Therapy
Summary:
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in
treating advanced or high-risk prostate cancer.
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Comron Hassanzadeh, MD
Phone:
713-657-9802
Email:
cjhassanzadeh@mdanderson.org
Investigator:
Last name:
Comron Hassanzadeh, MD
Email:
Principal Investigator
Start date:
June 27, 2024
Completion date:
September 1, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06369246
http://www.mdanderson.org
