Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

Description

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 boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.

Conditions

Prostate Cancer, Prostate Adenocarcinoma

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Study Overview

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Study Details

Study overview

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 boost (SIB) to the prostate that have been designed to incrementally increased the biological equivalent dose (BED) to prostate cancer, while maintaining a constant BED to normal tissue toxicity.

A Phase I Dose Escalation Study of Hypofractionated Accelerated Pelvic Nodal Radiotherapy Delivered With A Simultaneously Integrated Prostate Boost For Patients With Localized, Intermediate- And High-Risk Prostate Cancer (GCC 2048)

Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

Maryland Proton Treatment Center, Baltimore, Maryland, United States, 21201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patient age is ≥ 18 years
  • 2. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration.
  • 3. Patient's with intermediate to high risk prostate cancer and must be recommended to undergo pelvic as well as prostatic irradiation.
  • 4. 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.
  • 5. 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.
  • 6. No evidence of bone metastases (M0) on bone scan within 120 days prior to registration.
  • 7. Baseline serum PSA value performed within 12 weeks (90 days) prior to registration.
  • 8. ECOG Performance Status 0-1
  • 9. Patient must be able to provide study specific informed consent prior to study entry.
  • 1. Evidence of distant metastases
  • 2. Regional lymph node involvement
  • 3. Previous radical surgery (prostatectomy), cryosurgery, or HIFU (High-intensity focused ultrasound) for prostate cancer
  • 4. Previous pelvic irradiation or prostate brachytherapy
  • 5. Planned prostate brachytherapy boost
  • 6. Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • 7. 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.
  • 8. 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)
  • 9. Patients receiving full-dose anticoagulation or clopidogrel
  • 10. Patients with a history of prior small bowel ulceration

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Maryland, Baltimore,

Study Record Dates

2027-08