Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous I… (NCT05628363) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
United States28 participantsStarted 2023-01-18
Plain-language summary
This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Pathologically proven adenocarcinoma of the prostate with NCCN high-risk disease or NCCN unfavorable intermediate-risk disease.
* Patients with unfavorable intermediate-risk disease must meet the following criteria:
* At least one intermediate risk factor (IRF):
* PSA 10-20 ng/mL
* cT2b-c (AJCC 8th ed.)
* Gleason score 7
* At least one "unfavorable" intermediate-risk identifier:
* \> 1 IRF
* Gleason score 4+3
* ≥ 50% of biopsy cores positive
* NO high-risk features
* Patients with high-risk disease must meet at least one of the following criteria:
* cT3a-T3b
* PSA \> 20
* Gleason score ≥ 8
* MRI scan of the prostate with at least one MR-detectable lesion in the prostate/seminal vesicles. PET/CT which is found to display activity n the prostate consistent with prostate cancer may be substituted per investigator discretion.
* Planning to undergo concurrent whole-pelvis SBRT and androgen deprivation therapy (ADT). ADT may be initiated at any time per institutional standard, so long as ADT begins within 60 days of the start of radiotherapy.
* At least 18 years of age.
* ECOG performance status ≤ 1
* Agreement to adhere to Lifestyle Considerations throughout study duration
* Able to complete relevant patient-reported quality-of-life questionnaires in the opinion of the treating physician.
* Able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria:
* Definitive radio…
What they're measuring
1
Rate of acute grade ≥3 GI and GU adverse events
Timeframe: From start of radiotherapy through 90 days after start of radiotherapy