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Radiation Therapy Approaches for People with Prostate Cancer, BALANCE-RT Trial
Trial Status: active
This phase II trial compares the effect of stereotactic body radiation therapy (SBRT) alone to SBRT in combination with a high dose rate (HDR) brachytherapy boost in treating patients with higher-risk prostate cancer that has not spread to other parts of the body. 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. HDR brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. A radiation boost is one or more extra radiation treatments targeted at the tumor bed. Treatment usually includes HDR brachytherapy followed by SBRT, however, it is known that higher doses of radiation are effective in treating the tumor, but may also cause unwanted side effects. Patients may also receive hormone therapy with androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPIs) as part of standard of care. These drugs block hormones that play a role in tumor growth. Giving SBRT alone may be more effective than the usual treatment of SBRT in combination with a HDR brachytherapy boost in treating patients with higher risk prostate cancer that has not spread to other parts of the body while avoiding side effects.
Inclusion Criteria
Non-metastatic prostate cancer
Classified as unfavorable intermediate-, high-, or very high-risk prostate cancer according to National Comprehensive Cancer Network (NCCN) risk stratification guidelines. (Note: cT3a or T3b by MRI or prostate-specific membrane antigen [PSMA] positron emission tomography [PET] allowed)
Considered by the treating radiation oncologist as a suitable candidate for both HDR brachytherapy boost and SBRT
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07751159.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Daniel Gorovets
Phone: 212-639-3983
PRIMARY OBJECTIVE:
I. To determine whether SBRT alone results in less acute patient reported urinary symptoms measured by International Prostate Symptom Score (IPSS) at 3 months than HDR brachytherapy boost combined with SBRT.
KEY SECONDARY OBJECTIVE:
I. To determine late patient reported urinary symptom burden of SBRT plus HDR brachytherapy boost in comparison to SBRT alone.
SECONDARY OBJECTIVES:
I. To compare relative effects on:
Ia. Patient-reported quality of life for bowel and sexual function;
Ib. Acute and late physician-scored toxicity;
Ic. Radiographic response rate by multiparametric (mp) magnetic resonance imaging (MRI);
Id. Post-treatment rate of positive biopsies;
Ie. Biochemical failure rate;
If. Metastasis rate;
Ig. Rate of salvage therapy;
Ih. Prostate cancer specific mortality rate.
II. To evaluate feasibility of rectal spacer placement and potential impact on toxicity
III. To evaluate adaptive radiotherapy utilization and potential impact on toxicity outcomes
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo HDR brachytherapy boost. Starting about 4 weeks after HDR brachytherapy, patients undergo SBRT every other day for up to 5 treatment fractions. Patients also may receive ADT with or without ARPI for 4-24 months at the discretion of the treating physician in accordance with institutional standard practices. Additionally, patients undergo prostate biopsy post-radiation therapy and blood sample collection and computed tomography (CT) or MRI throughout the study.
ARM B: Patients undergo SBRT every other day for up to 5 treatment fractions. Patients also may receive ADT with or without ARPI for 4-24 months at the discretion of the treating physician in accordance with institutional standard practices. Additionally, patients undergo prostate biopsy post-radiation therapy and blood sample collection and CT or MRI throughout the study.
After completion of study treatment, patients are followed up at 3 and 24 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
