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

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ClinicalTrials.gov Identifier: NCT03388619
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : February 14, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


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.


To find the shortest radiation schedule that people can tolerate without strong side effects.


People at least 18 years old who have had a prostatectomy and will get radiation


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.

Condition or disease Intervention/treatment Phase
Cancer Of Prostate Prostate Neoplasms Prostate Cancer Neoplasms of Prostate Prostatic Cancer Radiation: Dose to prostate bed with integrated boost Radiation: Dose to prostate bed Phase 1

Detailed Description:


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.


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


  • 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


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 : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Dose to prostate bed with integrated boost
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
Experimental: 2
Dose to prostate bed
Radiation: Dose to prostate bed
Radiation will be delivered to the prostate bed only

Primary Outcome Measures :
  1. Define the maximum tolerated dose (MTD) [ Time Frame: 3 weeks after radiation ]

Secondary Outcome Measures :
  1. List of adverse event frequency [ Time Frame: 3 weeks after radiation ]
  2. The rate of PSA control [ Time Frame: 1 and 2 years after treatment ]
  3. Proportion of patients that have improvement in quality of life aftertreatment [ Time Frame: 1 and 2 years after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
  • 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.


  • Patients who are receiving any other investigational agents concurrently.
  • Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed).
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388619

Contact: Theresa Cooley-Zgela, R.N. (240) 760-6207 theresa.cooleyzgela@nih.gov

United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Deborah E Citrin, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03388619     History of Changes
Other Study ID Numbers: 180028
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: January 10, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Rising PSA
No evidence of metastatic disease
Entire Prostate Bed
Quality of Life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases