High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT05754580
Status
Recruiting
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Conditions

  • Prostatic Cancer

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Dose Brachytherapy — RADIATION
    This technique involves transient insertion of a stronger (i.e. more active) source (Ir-192) into the prostate, with dose delivery over the course of several minutes followed by immediate removal.
  • Stereostatic Body Radiation Therapy — RADIATION
    ultra-hypofractionation radiation therapy.

Study Details

The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.

Key Dates

Start date
Aug 29, 2023
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High Dose Rate (HDR) Brachytherapy and Stereoscopic Body Radiation (SBRT) treatment
    High dose rate Brachytherapy in combination with stereoscopic body radiation therapy.

Primary Outcome Measure

Number of Participants with Treatment-Related Adverse Events [ Time Frame: between the start of treatment up to 6 months post-treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Heather D Mittelstedt, RN
[email protected]
402-559-8278

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NE

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