RECRUITING

Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)

Conditions

Prostate Cancer Prostate Adenocarcinoma Prostate Hypofractionated Radiation Therapy Radiotherapy Proton Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2020-11-19

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04486755

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Mark Mishra, MD

CONTACT

4103286080

mmishra@umm.edu

Acara Carter

CONTACT

410-369-5350

acara.carter@umm.edu

Study Locations (Sites)

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-19

Study Completion Date2027-08

Study Record Updates

Study Start Date2020-11-19

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Prostate
Hypofractionated Radiation Therapy
Prostate Cancer
Radiotherapy
Proton Therapy

Additional Relevant MeSH Terms

Prostate Cancer
Prostate Adenocarcinoma