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Recruiting NCT07751159

Radiation Therapy Approaches for People With Prostate Cancer

Phase II Interventional Prostate Cancer Patients Non-metastatic Prostate Cancer High Risk Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brachytherapy, SBRT.
Who it may be relevant to
Registry conditions: Prostate Cancer Patients, Non-metastatic Prostate Cancer, High Risk Prostate Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Balancing Radiation Intensification and Quality of Life in Higher-Risk Prostate Cancer (The BALANCE-RT Trial)

Overview

The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.

Interventions

  • Radiation Brachytherapy
    Standard of care Brachytherapy
  • Drug SBRT
    SBRT alone

Primary outcome measures

  • Change in International Prostate Symptom Score / IPSS at 3 months [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Non-metastatic prostate cancer.
  • Classified as unfavorable intermediate-, high-, or very high-risk prostate cancer according to NCCN risk stratification guidelines. (Note: cT3a or T3b by MRI or PSMA PET allowed)
  • Considered by the treating radiation oncologist as a suitable candidate for both HDR brachytherapy boost and SBRT (see clinical considerations for treatment eligibility below)

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering at Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering at Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
  • Memorial Sloan Kettering at Nassau (Limited Protocol Activities) — Uniondale

Identifiers

NCT: NCT07751159 · 26-288

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗