Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06205316 · ClinicalTrials.gov registry record · Phase 3
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
A Phase 3 study of Stage IV Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 6
- Study locations
NCT06205316: Recruiting Phase 3 study of Stage IV Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
NCT06205316 is a Phase 3 study of Stage IV Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 118 participants, below the 152-participant average among 28 other Stage IV Prostate Cancer AJCC v8 trials with a reported enrollment target (22% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06205316, a Phase 3 study of Stage IV Prostate Cancer AJCC v8 and Stage III Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.
Primary Outcome
Defined as the proportion of patients experiencing an increase in GU/GI Common Terminology Criteria for Adverse Events version 5.0 to grade 3+ compared to pre-radiation therapy GU/GI toxicity over the number of patients eligible for toxicity evaluation at 2 years from the start of radiation therapy. This endpoint will be compared between patients treated with stereotactic body radiation therapy and hypofractionated radiation therapy.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Positron Emission Tomography
- RADIATION Stereotactic Body Radiation Therapy
- DRUG Antiandrogen Therapy
- RADIATION Hypofractionated Radiation Therapy
Study Locations (6)
Minnesota
- Mayo Clinic Health System in Albert Lea - Albert Lea
- Mayo Clinic Health System - Mankato - Mankato
- Mayo Clinic in Rochester - Rochester
Wisconsin
- Mayo Clinic Health System-Eau Claire Clinic - Eau Claire
- Mayo Clinic Health System-Franciscan Healthcare - La Crosse
Arizona
- Mayo Clinic in Arizona - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2024-01-22 |
| Est. Completion | 2030-01-22 |
| Phase | Phase 3 |
What NCT06205316 shows while recruiting
NCT06205316 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 152-participant average among 28 other Stage IV Prostate Cancer AJCC v8 trials with a reported enrollment target (22% lower).
The record links to 7 conditions, with Stage IV Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06205316 lists 6 locations in 3 states (Minnesota, Wisconsin, Arizona).
Frequently Asked Questions
What is clinical trial NCT06205316 about?
NCT06205316 is a clinical study titled "SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma". This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary ...
What is the current status of trial NCT06205316?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2024-01-22. Estimated completion is 2030-01-22.
What conditions does trial NCT06205316 study?
This clinical trial studies the following conditions: Stage IV Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Biochemically Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT06205316?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Positron Emission Tomography (PROCEDURE), Stereotactic Body Radiation Therapy (RADIATION), Antiandrogen Therapy (DRUG), Hypofractionated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06205316?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06205316 being conducted?
This trial has 6 study locations across Arizona, Minnesota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06205316's enrollment target sits among peer trials
118 9th of 28 higher than 20 of 28 other Stage IV Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
RECRUITING · Phase 3
-
A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
ACTIVE NOT RECRUITING · Phase 3
-
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
RECRUITING · Early Phase 1
-
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
RECRUITING · Phase 2
-
Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
RECRUITING · Phase 2
-
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03821623 · 118 participants · Phase 2
Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
- NCT04040959 · 118 participants · Phase 2
Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD
- NCT04696029 · 118 participants · Phase 2
DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
- NCT05223192 · 118 participants · NA
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI