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Protocol Details

A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Rising PSA;
No evidence of metastatic disease;
Entire Prostate Bed;
Quality of Life;

Recruitment Keyword(s)



Cancer Of Prostate;
Prostate Neoplasms;
Prostate Cancer;
Neoplasms of Prostate;
Prostatic Cancer

Investigational Drug(s)


Investigational Device(s)



Radiation: Dose to prostate bed with integrated boost
Radiation: Dose to prostate bed irradiation only

Supporting Site

National Cancer Institute


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.

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- 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 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)

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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.

Christie 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.

Dearnaley 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.

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Principal Investigator

Referral Contact

For more information:

Deborah E. Citrin, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3532
(240) 760-6206

Debbie Nathan, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 2-1730
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8968

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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