Localized Prostate Carcinoma, Prostate Adenocarcinoma
Conditions
Keywords
Brachytherapy, Radiotherapy, High Dose Rate
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. To determine the safety of HDR monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart in patients with low and intermediate risk prostate cancer. SECONDARY OBJECTIVES: I. To describe the prostate specific antigen (PSA) kinetics associated with HDR brachytherapy monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart for low and intermediate risk prostate cancer. OUTLINE: Treatment will be administered on an outpatient basis. All treatment will be delivered over a single day. Participants will be followed for 6 months after last treatment or removal from study, or until death, whichever occurs first. Additional Follow up will be as per usual guidelines for prostate cancer, every 3 months following treatment with PSA for the first year, then every 4 months after year 2, and every 6 months after year 3 until 5 years of follow up are completed.
Interventions
RADIATIONHigh Dose Rate Monotherapy
High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. 2. 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). 3. Age \>=18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%). 5. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist. 6. Ability to understand and the willingness to sign a written informed consent document. 7. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 9. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 10. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 11. Willingness and ability to complete International Prostate Symptom Score questionnaires.
Exclusion criteria
1. Any prior treatment for prostate cancer. 2. Prior history of pelvic malignancy. 3. Any prior androgen deprivation therapy. 4. Is currently receiving any other investigational agents. 5. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure. 6. Contraindications to general anesthesia. 7. Contraindications to radiotherapy. 8. Prior history of pelvic radiotherapy. 9. Presence of lymph node or distant metastases. 10. Prior cryosurgery or cryotherapy to the prostate. 11. Prior transurethral resection of the prostate (TURP) or transurethral incision within the previous 6 months. 12. Estimated prostate volume \>60 cubic centimeters as determined by transrectal ultrasound or magnetic resonance imaging. 13. IPSS score of 15 or higher prior to treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with treatment-related adverse events | Up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Prostate Specific Antigen (PSA) Nadir | Up to 6 months | The mean (average) PSA nadir after treatment will be reported along with standard deviations. |
| Mean Time to PSA Nadir | Up to 6 months | The mean (average) time to PSA nadir after treatment will be reported along with standard deviations. |
| Mean Change in International Prostate Symptom Score (IPSS) over time | Up to 6 months | 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. |
Countries
United States
Contacts
CONTACTImani Dunn
PRINCIPAL_INVESTIGATORI-Chow Hsu, MD
University of California, San Francisco
Outcome results
None listed