Status:
ACTIVE_NOT_RECRUITING
Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cancer Of Prostate
Prostate Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
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. ...
Detailed Description
BACKGROUND: Prostate cancer that recurs after prostatectomy (rising prostate-specific antigen (PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed t...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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)
Exclusion
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03388619
Start Date
January 17 2018
End Date
December 8 2025
Last Update
May 8 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892