Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
2 other identifiers
interventional
30
1 country
1
Brief Summary
Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans. Objective: To find the shortest radiation schedule that people can tolerate without strong side effects. Eligibility: People at least 18 years old who have had a prostatectomy and will get radiation. Design: Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Scan that uses a small amount of radiation to make a picture of the body
- Scan that uses a magnetic field to make an image of the body
- Participants will provide documents that confirm their diagnosis.
- Participants may have a scan of the abdomen and pelvis. Before they start treatment, participants will have another physical exam and blood tests. Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks. Participants may provide a tissue sample from a previous procedure for research. Participants will answer questions about their general well-being and function. About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2017
CompletedFirst Posted
Study publicly available on registry
January 3, 2018
CompletedStudy Start
First participant enrolled
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedResults Posted
Study results publicly available
May 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2025
CompletedMay 27, 2026
May 1, 2026
6 years
December 30, 2017
February 28, 2024
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy)
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
3 weeks after radiation
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
3 weeks after radiation
Secondary Outcomes (9)
Biochemical Progression Free Survival (bPFS)
1 and 2 years after treatment
Changes in Quality of Life (QOL) Scores After Treatment
baseline, 1 and 2 years after treatment
Changes in Erectile Dysfunction After Treatment Measured by the Sexual Health Inventory for Men (SHIM)
2 years after treatment
American Urologic Association Symptom Index Score (AUA-SI)
2 years after treatment
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short Form (SF) 4a:
2 years after treatment
- +4 more secondary outcomes
Other Outcomes (2)
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Date treatment consent signed to date off study, an average of 25 months
Number of Participants With a Dose-limiting Toxicity (DLT)
3 weeks after radiation
Study Arms (2)
Arm 1/Prostate Bed with Integrated Boost
EXPERIMENTALProstate bed with integrated boost.
Arm 2/Prostate Bed Irradiation Only
EXPERIMENTALProstate bed irradiation only.
Interventions
Radiation will be delivered at an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed.
At screening, if required by clinician.
Radiation will be delivered to the prostate bed only.
At screening, if required by clinician.
Computed tomography of the abdomen and pelvis if clinically indicated at screening, with oral and intravenous contrast.
mpMRI of the prostate bed at screening and 6 month follow up.
After enrollment if clinically indicated (i.e., anti-androgen, gonadotropin releasing hormone agonist, or combination of both).
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- Indications for post-prostatectomy radiation exist:
- Disease progression (detectable prostate-specific antigen (PSA) on two measurements obtained at least one month apart) or
- indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy).
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 60)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last radiation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
- Human immunodeficiency virus (HIV) positive patients are included if CD4+ (cytotoxic T cells) T-cell count \> 200 cells/uL; on stable antiretroviral therapy for \> 1 year with HIV viral load \<200 copies/mL, and no history of opportunistic infections in \> 1 year.
You may not qualify if:
- Patients who are receiving any other investigational agents concurrently.
- Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region).
- History of radiation that would overlap with the intended treatment to the prostate bed.
- Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi's Anemia)
- Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results.
- Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
Shaikh T, Li T, Handorf EA, Johnson ME, Wang LS, Hallman MA, Greenberg RE, Price RA Jr, Uzzo RG, Ma C, Chen D, Geynisman DM, Pollack A, Horwitz EM. Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):722-731. doi: 10.1016/j.ijrobp.2016.12.034. Epub 2016 Dec 28.
PMID: 28244407BACKGROUNDChristie DR, Sharpley CF, Bitsika V. Why do patients regret their prostate cancer treatment? A systematic review of regret after treatment for localized prostate cancer. Psychooncology. 2015 Sep;24(9):1002-11. doi: 10.1002/pon.3776. Epub 2015 Mar 1.
PMID: 25728586BACKGROUNDDearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
PMID: 27339115BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Deborah E. Citrin
- Organization
- National Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah E Citrin, M.D.
National Cancer Institute (NCI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
December 30, 2017
First Posted
January 3, 2018
Study Start
January 17, 2018
Primary Completion
December 29, 2023
Study Completion
December 4, 2025
Last Updated
May 27, 2026
Results First Posted
May 14, 2024
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
- Access Criteria
- Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).