NCT01923506Active, not recruitingPhase 1
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 13 Aug 2013
- Start date
- 25 Nov 2013
- Primary completion date
- 28 Jun 2027
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT01923506
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 25 Nov 2013 to the primary completion date, 28 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy
- Study-specific exclusions:
- History of prior radiation to the pelvis
- History of uncontrolled inflammatory bowel disease
- Unable to comply with radiation therapy procedures
Other illness
- Patients should not have any uncontrolled illness including ongoing or active infection
- Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years
Other
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Who the study is looking for
- History of diagnosis of prostate cancer after undergoing prostatectomy
- No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic
- Eastern Cooperative Oncology Group (ECOG) performance scale 0-2
- Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
- Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry
- PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Age in the registry: 19 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.