Could a few weeks of radiation be enough for recurrent prostate cancer?
NCT ID NCT03388619
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This early-phase trial tested a shorter course of radiation for men whose prostate cancer came back after their prostate was removed. Instead of the usual 6-7 weeks of daily radiation, researchers gave higher doses over just 2-4 weeks, focusing the strongest radiation on the tumor seen on scans. The goal was to find the shortest schedule that men could tolerate without serious side effects. 30 men participated, and the study is now complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If successful, this could lead to a shorter, more convenient radiation schedule for men whose prostate cancer returns after surgery, with fewer side effects.
- What could go wrong
- This is a very early phase 1 trial with only 30 participants, so it is not yet clear if the shorter schedule is as effective as the standard longer one. Side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Jan 2018
- Finished
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Dec 2025
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
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