Two-fraction HDR Monotherapy for Localized Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco
About this trial
This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
National Comprehensive Cancer Network favorable intermediate risk stratification, defined as one or more intermediate risk factors such as cT2b - cT2c category, grade group 1 or 2, or PSA 10-20 ng/mL, and less than 50% of biopsy cores positive for carcinoma (i.e. for this trial, we will only include systematic biopsy cores, not targeted biopsy cores).
Age >=18 years.
Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%).
Disqualifiers
Any prior treatment for prostate cancer.
Prior history of pelvic malignancy.
Any prior androgen deprivation therapy.
Is currently receiving any other investigational agents.
Trial design
Design model
Single group
Treatments tested in this trial
High Dose Rate Monotherapy
RadiationHigh dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: HDR brachytherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with treatment-related adverse events
The proportion of participants with reported grade 3 or higher genitourinary (GU) or gastrointestinal (GI) toxicities, as graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.
Time frame
Up to 6 monthsSecondary outcomes
1
Mean Prostate Specific Antigen (PSA) Nadir
The mean (average) PSA nadir after treatment will be reported along with standard deviations.
Time frame
Up to 6 months2
Mean Time to PSA Nadir
The mean (average) time to PSA nadir after treatment will be reported along with standard deviations.
Time frame
Up to 6 months3
Mean Change in International Prostate Symptom Score (IPSS) over time
The mean change over time on scores for the International Prostate Symptom Score (IPSS) will be reported along with standard deviations. The IPSS measures the severity of lower urinary tract symptoms and erectile function with lower numbers indicating less change in symptoms. Seven questions with scores ranging from 1-5 are summed to create a total score. Scores of 1-7 indicate mild symptoms, scores of 8-19 indicate moderate symptoms, and scores of 20-35 indicate severe symptoms.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov