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New treatment option for Advanced Prostate Cancer
Official title PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.
ClinicalTrials.gov ID: NCT06369246
What this study is testing
- What it's testing
- To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen...
- 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, PSA \>10 ng/mL prior to starting...
- Node negative by conventional imaging.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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, PSA \>10 ng/mL prior to starting androgen deprivation therapy (ADT). If a participant is taking 5-alpha...
- 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...
- ECOG performance status 0-2.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.