University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT06591819
This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results.
Brachytherapy boost will be delivered and then whole pelvis proton radiation therapy in 5 fractions.
Time frame: First year of treatment
The technique will be deemed safe if <10% of patients experience a CTCAE version 5.0 grade 3 or higher genitourinary or gastrointestinal toxicity cumulatively.
Time frame: First year of treatment
To evaluate for multiple domains of quality of life before and after radiotherapy by using validated surveys including EPIC-26 in urinary continence, urinary obstruction, bowel, and sexual domains. Investigators will determine minimally important differences for each domain.
Time frame: First year of treatment
To determine treatment efficacy of proton radiotherapy for all enrolled patients as evidenced by biochemical control in the months following radiation. Investigators will follow PSA to determine if there is evidence for biochemical recurrence following radiotherapy. PSA recurrence will be defined as an increase of 2 ng/ml higher than the nadir value following completion of radiotherapy.
Contact information is provided by the study sponsor or research team.
Abramson Cancer Center at Penn Medicine
Other
Safety of Hypofractionated Whole-Pelvis Proton Therapy With HDR Boost
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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