Prostate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8
Conditions
Brief summary
This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.
Detailed description
PRIMARY OBJECTIVES: I. Estimate local control. II. Estimate acute/late grade 2+ genitourinary (GU)/gastrointestinal (GI) toxicity. SECONDARY OBJECTIVES: I. Prostate specific antigen (PSA) response at 6 weeks after radiation therapy (RT), every 3 months for 24 months, every 6 months to 60 months, then every 8-12 months until 5 years. II. Clinical progression free survival/biochemical progression free survival at 5 years. III. Distant metastasis free survival. IV. Development of castration-resistant disease. V. Overall survival. VI. Changes in quality of life VIa. Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire; VIb. Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire. OUTLINE: Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, multiparametric (mp) magnetic resonance imaging (MRI) and optionally prostate-specific membrane antigen (PSMA) positron emission tomography (PET) throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study. After completion of study treatment, patients are followed up at 6 weeks, every 3 months for the first 2 years, every 6 months for years 3 and 4, then annually thereafter.
Interventions
PROCEDUREBiopsy Procedure
Undergo tumor biopsy
PROCEDUREBiospecimen Collection
Undergo blood sample collection
RADIATIONHigh-Dose Rate Brachytherapy
Undergo HDR-BT
Undergo mpMRI
PROCEDUREPSMA PET Scan
Undergo PSMA PET
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy * Multiparametric MRI (mp-MRI) confirmed lesion(s) * No distant or locally advanced disease on standard staging exams as indicated * Bone scan and abdominopelvic computed tomography (CT)/MRI OR * PSMA PET * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment * Age ≥ 40
Exclusion criteria
* Radiographic nodal or distant metastatic disease * Lesion(s) comprising \> 40% of total prostate volume * Prior radiotherapy to the pelvis * Gleason score \> 6 disease outside intended gross target volume (GTV)/target region(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 2 or greater genitourinary adverse events (AEs) | Up to 6 years | Will be defined as the percentage of patients who encounter the AE of specific grade or worse using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be calculated to indicate the toxicity level of focal radiation therapy (RT), along with the corresponding 95% Clopper-Pearson exact confidence interval. |
| Incidence of grade 2 or greater gastrointestinal AEs | Up to 6 years | Will be defined as the percentage of patients who encounter the AE of specific grade or worse using CTCAE v 5.0. Will be calculated to indicate the toxicity level of focal RT, along with the corresponding 95% Clopper-Pearson exact confidence interval. |
| Time to first grade 2 or greater adverse event | Up to 6 years | Will be analyzed as a time-to-event outcome using Kaplan-Meier (KM) methods. |
| Local control rate | Up to 6 years | Will be defined as lack of biopsy proven progression within target/treated region/lesion. The proportion of patients achieving local control will be estimated along with the corresponding 95% Clopper-Pearson exact confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate specific antigen (PSA) response | At 3, 6, 12 and 24 months | PSA changes over time will be assessed via repeated measures analysis of variance (ANOVA). If significant PSA changes over time are identified by repeated measures ANOVA, the individual comparisons between time points will be evaluated via Tukey's Honestly Significant Difference test as the method of accommodating multiple comparisons. |
| Biochemical progression free survival | Up to 5 years | Will be obtained via KM analysis to provide an overview of efficacy for focal RT. |
| Clinical progression free survival | Up to 5 years | Will be obtained via KM analysis to provide an overview of efficacy for focal RT. |
| Distant metastasis free survival | Up to 5 years | Will be obtained via KM analysis to provide an overview of efficacy for focal RT. |
| Overall survival | Up to 6 years | Will be obtained via KM analysis to provide an overview of efficacy for focal RT. |
| Patient reported quality of life | Up to 6 years | Will be evaluated using Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P). The FACT-P uses a 5-point Likert scale for scoring, with total scores ranging from 0 to 156. Higher scores indicate better quality of life. The change of the scores between the time of pre-focal RT and post-focal RT will be assessed via two-sided paired t-test. |
| Expanded Prostate Cancer Index Composite Short Form questionnaire score | Up to 6 years | The change of the scores between the time of pre-focal RT and post-focal RT will be assessed via two-sided paired t-test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlan C Lee
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed