NCT06369246 PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.
| NCT ID | NCT06369246 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Advanced Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2024-06-27 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Comron Hassanzadeh, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06369246 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06369246 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06369246 currently recruiting?
Yes, NCT06369246 is actively recruiting participants. Contact the research team at cjhassanzadeh@mdanderson.org for enrollment information.
Where is the NCT06369246 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06369246 clinical trial?
NCT06369246 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Comron Hassanzadeh, MD at M.D. Anderson Cancer Center. The trial plans to enroll 70 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.