Status:
RECRUITING
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
A phase I trial to determine the safety of delivering three sequentially shorter RT schedules (20, 16, and 12 fractions) of HypoFx pelvic nodal RT in combination with a HypoFx, simultaneous integrated...
Detailed Description
Outcomes for patients with unfavorable intermediate-risk and high-risk prostate cancer (PC) have been historically poor and are now known to require multimodality treatment. A standard non-surgical tr...
Eligibility Criteria
Inclusion
- Patient age is ≥ 18 years
- Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration.
- Patient's with intermediate to high risk prostate cancer and must be recommended to undergo pelvic as well as prostatic irradiation.
- History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
- Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 120 days prior to registration.
- • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration.
- • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
- Baseline serum PSA value performed within 12 weeks (90 days) prior to registration.
- ECOG Performance Status 0-1
- Patient must be able to provide study specific informed consent prior to study entry.
Exclusion
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy), cryosurgery, or HIFU (High-intensity focused ultrasound) for prostate cancer
- Previous pelvic irradiation or prostate brachytherapy
- Planned prostate brachytherapy boost
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
- Patients are excluded if they have a history of autoimmune disease that, in the opinion of the treating physician would be a contraindication to pelvic radiation (e.g., active systemic lupus, progressive scleroderma)
- Patients receiving full-dose anticoagulation or clopidogrel
- • Patients taking 81 mg Aspirin po daily may are still eligible for the study
- Patients with a history of prior small bowel ulceration
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04486755
Start Date
November 19 2020
End Date
August 1 2027
Last Update
June 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201