NCT05946824RecruitingPhase 2
This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.
Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 8 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 6 Jun 2023
- Start date
- 14 Dec 2023
- Primary completion date
- 24 Nov 2025
- Lead sponsor
- University of Rochester
- Diseases
- Prostate cancer
- NCT number
- NCT05946824
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 14 Dec 2023 to the primary completion date, 24 Nov 2025
- 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
- Prior radiation therapy to the pelvis region
Other illness
- Metastatic disease
- Inflammatory bowel disease
Other
- Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months
- Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months
- PSA \>10 ng/dl at study entry,
Who the study is looking for
- Adenocarcinoma of the prostate with previous surgical resection
- Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation
- Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field
- At least two serum detectable PSA levels defined as \>0.02 ng/dl at least 30 days apart.
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wilmot Cancer Institute - Dept of Radiation Oncology Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.