Advanced Prostate CancerPhase 2NCT06369246
PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.
A Phase 2 study testing Stereotactic Body Radiation Therapy in people with Advanced Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, 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).
- Node negative by conventional imaging.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Comron Hassanzadeh, MD, 713-657-9802, cjhassanzadeh@mdanderson.org
Comron Hassanzadeh, MD
About this study
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.
Read the 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.
- Conditions
- Advanced Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyDevice
Undergo Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Participants will then be scheduled to receive radiation therapy. Radiation will be given over 5 sessions, 2-3 times per week, for 2 weeks. Each radiation therapy session will take 15-30 minutes to complete.
Within 1 day after completing radiation therapy, blood (about 2 tablespoons) will be drawn for routine tests. Receives: Device: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start27 Jun 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Comron Hassanzadeh, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369246
- Sponsor's protocol ID
- 2023-0893
- Other IDs
- NCI-2024-03308
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.
- ClinicalTrials.gov ID
- NCT06369246
- Acronym / sponsor ID
- 2023-0893
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Device: Stereotactic Body Radiation TherapyParticipants will then be scheduled to receive radiation therapy. Radiation will be given over 5 sessions, 2-3 times per week, for 2 weeks. Each radiation therapy session will take 15-30 minutes to complete. Within 1 day after completing radiation therapy, blood (about 2 tablespoons) will be drawn for routine tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation TherapyUndergo Radiation Therapy | Device | Stereotactic Body Radiation Therapy |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Comron Hassanzadeh, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy in people with Advanced Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Comron Hassanzadeh, MD ((713) 657-9802, cjhassanzadeh@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.