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Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388619
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE December 30, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE January 17, 2018
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2018)
Define the maximum tolerated dose (MTD) [ Time Frame: 3 weeks after radiation ]
Define the maximum tolerated dose (MTD) hypofractionated of image guided, focally dose escalated post-prostatectomy radiation.
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
Define the maximum tolerated dose (MTD) [ Time Frame: 3 weeks after radiation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • List of adverse event frequency [ Time Frame: 3 weeks after radiation ]
    Define the toxicity profile of image-guided, focally dose escalated prostate bed radiation in patients with a local or regional recurrence of prostate cancer after prostatectomy.
  • The rate of PSA control [ Time Frame: 1 and 2 years after treatment ]
    Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model
  • Proportion of patients that have improvement in quality of life aftertreatment [ Time Frame: 1 and 2 years after treatment ]
    The quality of life scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for patient-specific trajectory of quality of life scores.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
  • List of adverse event frequency [ Time Frame: 3 weeks after radiation ]
  • The rate of PSA control [ Time Frame: 1 and 2 years after treatment ]
  • Proportion of patients that have improvement in quality of life aftertreatment [ Time Frame: 1 and 2 years after treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
Official Title  ICMJE A Phase I Trials of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
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.

Detailed Description

BACKGROUND:

Prostate cancer that recurs after prostatectomy (rising PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gy over 6-7 weeks. This treatment can provide PSA control in approximately 75% of patients, but may have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder. Imaging of prostate cancer has improved to the extent that recurrent disease is often identified in the prostate bed or in other pelvic sites. The current standard is to irradiate the entire prostate bed to the total dose. This trial will test the tolerability of accelerated treatment designed to yield a similar rate of late toxicity. In addition, in patients with visible tumor, it will test the feasibility of delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the visible tumor to allow a higher dose to visible tumor than can be delivered with standard approaches.

OBJECTIVE:

- Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose escalated post-prostatectomy radiation.

ELIGIBILITY:

  • PSA recurrence after prostatectomy or indications for adjuvant radiation after prostatectomy.
  • No evidence of distant metastases of prostate cancer (pelvic lymph nodes are allowed).
  • Age greater than or equal to 18 years old
  • ECOG performance status less than or equal to 1

DESIGN:

This is a Phase I trial of hypofractionated, focal dose escalation with reduced dose prostate bed irradiation using image and pathologic guidance. The prostate bed will be treated with hypofractionated radiation and areas in the prostate bed or pelvis shown to have tumor on biopsy or with advanced imaging studies will be treated with an integrated boost to visible tumor. The treatment duration will be decreased sequentially in three Dose Level groups. Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires. A maximum of 48 patients will be enrolled.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer Of Prostate
  • Prostate Neoplasms
  • Prostate Cancer
  • Neoplasms of Prostate
  • Prostatic Cancer
Intervention  ICMJE
  • Radiation: Dose to prostate bed with integrated boost
    Radiation will be delivered to an escalated dose to areas of recurrent prostate cancer identified on imaging and a reduced dose will be delivered to the entire prostate bed
  • Radiation: Dose to prostate bed
    Radiation will be delivered to the prostate bed only
Study Arms  ICMJE
  • Experimental: 1/Prostate bed with integrated boost
    Dose to prostate bed with integrated boost
    Intervention: Radiation: Dose to prostate bed with integrated boost
  • Experimental: 2/Prostate bed irradiation only
    Dose to prostate bed irradiation only
    Intervention: Radiation: Dose to prostate bed
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:
  • Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Indications for post-prostatectomy radiation exist:

    • Disease progression (detectable 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.
  • 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.
  • HIV positive patients are included if CD4+ 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.

EXCLUSION CRIETERIA:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Theresa Cooley-Zgela, R.N. (301) 451-8905 theresa.cooleyzgela@nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03388619
Other Study ID Numbers  ICMJE 180028
18-C-0028
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 8, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP