Description:
This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic
body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also
known as internal radiation therapy, uses radioactive material placed directly into or near a
tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to
position a patient and deliver radiation to tumors with high precision. This method may kill
tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Title
- Brief Title: High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
- Official Title: Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
Clinical Trial IDs
- ORG STUDY ID:
21-000704
- SECONDARY ID:
NCI-2021-05623
- NCT ID:
NCT04945642
Conditions
- Prostate Adenocarcinoma
- Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8
- Stage IIC Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IIIA Prostate Cancer AJCC v8
- Stage IIIB Prostate Cancer AJCC v8
- Stage IIIC Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
Purpose
This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic
body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also
known as internal radiation therapy, uses radioactive material placed directly into or near a
tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to
position a patient and deliver radiation to tumors with high precision. This method may kill
tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the biochemical progression-free survival (b-PFS) at the 5-year time point
after combination therapy of stereotactic body radiotherapy (SBRT) and high dose rate
(HDR)-brachytherapy (BT) boost stratified by patients with intermediate and high-risk
prostate cancer.
II. To estimate the rate of acute >= grade 3 patient-reported genitourinary (GU) and
gastrointestinal (GI) symptoms determined within 90 days after treatment completion,
respectively.
SECONDARY OBJECTIVES:
I. To estimate patient-reported GU symptoms at the end of radiotherapy and within 6, 12, 24,
and 60 months from radiotherapy completion.
II. To estimate patient reported GI symptoms at the end of radiotherapy and within 6, 12, 24,
and 60 months from radiotherapy completion.
III. To estimate the cumulative incidence of acute grade >= 2 GU physician-scored toxicity,
as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale.
IV. To estimate the cumulative incidence of acute grade >= 2 GI physician-scored toxicity, as
assessed by the CTCAE version 5.0 scale.
V. To estimate the cumulative incidence of late >= 2 GU physician-scored toxicity, as
assessed by the CTCAE version 5.0 scale.
VI. To estimate the cumulative incidence of late >= 2 GI physician-scored toxicity, as
assessed by the CTCAE version 5.0 scale.
VII. To determine the prostate specific antigen (PSA) complete response rate (PSA nadir =<
0.3ng/mL) at 3 months following treatment of combination SBRT and HDR-BT boost regardless of
testosterone recovery.
VIII. To determine clinical progression-free survival at 5-years. IX. To determine distant
metastasis-free survival at 5-years. X. To determine overall survival at 5-years.
OUTLINE:
Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive
days for up to 14 consecutive chronologic days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up within 90 days, every 3 months
for 24 months, and then every 6 months for up to 5 years.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Treatment (HDR-BT, SBRT) | Experimental | Patients undergo HDR-BT for up to 24 hours and undergo SBRT every other day or consecutive days for up to 14 consecutive chronologic days in the absence of disease progression or unacceptable toxicity. | |
Eligibility Criteria
Inclusion Criteria:
- Ability to understand a written informed consent document, and the willingness to sign
it
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- History/physical examination with digital rectal examination of the prostate within 8
weeks prior to registration
- Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b,
PSA > 10, and/or Gleason score >= 7
- No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no
suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
- Prostate size =< 60cc
- International Prognostic Scoring System (IPSS) score =< 15
- Able to safely receive moderate sedation or general anesthesia
Exclusion Criteria:
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or
lymphomatous/hematogenous malignancy unless continually disease free for a minimum of
5 years
- Regional lymph node involvement
- Evidence of distant metastases
- Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused
ultrasound for prostate cancer
- Previous pelvic irradiation or prostate brachytherapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative
colitis), high predisposition for radio-toxicity compared to general population (i.e.,
ataxia telangiectasia), or at risk for major bowel surgery
- Transurethral resection of the prostate (TURP) procedure within 6 months of radiation
treatment
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Biochemical failure |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Will be based on Phoenix criteria (either a rise of 2 ng/mL or more above nadir prostate specific antigen [PSA], or patients not meeting this criterion but underwent salvage therapies). The biochemical progression free survival (b-PFS) will be defined from the date of completing radiotherapy to the date biochemical failure, death, or last follow-up, stratified by prostate cancer risk classification. Kaplan-Meier method will be used. |
Secondary Outcome Measures
| Measure: | Patient-reported GU symptoms |
| Time Frame: | At end of radiotherapy, 6, 12, 24, and 60 months |
| Safety Issue: | |
| Description: | Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL. |
| Measure: | Patient-reported GI symptoms |
| Time Frame: | At end of radiotherapy, 6, 12, 24, and 60 months |
| Safety Issue: | |
| Description: | Will be assessed on EPIC-26. EPIC assesses the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL. |
| Measure: | The acute grade >= 2 GU physician-scored toxicity |
| Time Frame: | Up to 90 days from treatment completion |
| Safety Issue: | |
| Description: | Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Measure: | The acute grade >= 2 GI physician-scored toxicity |
| Time Frame: | Up to 90 days from treatment completion |
| Safety Issue: | |
| Description: | Will be assessed by CTCAE version 5.0. |
| Measure: | The late grade >= 2 GU physician-scored toxicity |
| Time Frame: | 90 days from treatment completion, assessed up to 5 years |
| Safety Issue: | |
| Description: | Will be assessed by CTCAE version 5.0. |
| Measure: | The late grade >= 2 GI physician-scored toxicity |
| Time Frame: | 90 days from treatment completion, assessed up to 5 years |
| Safety Issue: | |
| Description: | Will be assessed by CTCAE version 5.0. |
| Measure: | PSA complete response |
| Time Frame: | 3 months after treatment completion |
| Safety Issue: | |
| Description: | Will be defined as PSA =< 0.3 ng/mL three months after treatment completion. |
| Measure: | Clinical disease progression to any anatomical site |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Will be based on patient history, physical examination, or imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]). |
| Measure: | Clinical distant disease progression to anatomical sites outside prostate and regional lymph nodes |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Will be based on imaging (CT, PET). |
| Measure: | Number of participants lost-to-follow-up |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Number of deaths or patients lost-to follow-up during the follow-up period |
| Measure: | Progression-free survival |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Will be estimated by the Kaplan-Meier method. |
| Measure: | Distant disease-free survival |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Will be estimated by the Kaplan-Meier method. |
| Measure: | Overall survival |
| Time Frame: | Up to 5 years |
| Safety Issue: | |
| Description: | Will be estimated by the Kaplan-Meier method. |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Jonsson Comprehensive Cancer Center |
Last Updated
July 15, 2021
