Hypofractionated Whole Pelvic Radiotherapy of the Prostate
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Helical TomoTherapy (HT)
CyberKnife SBRT
Permanent Prostate Implant (PPI)
HDR brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA >10, and/or Gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation.
- History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
- Zubrod performance status 0-2
- Age ≥18 years
- Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Patients with history of inflammatory bowel disease or major bowel surgery.
- Prior transurethral resection of the prostate (TURP) procedure.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Step 1: Pelvic Lymph Node Irradiation Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each Step 2: Treat boost volume to prostate and seminal vesicles Acceptable treatment modalities: CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT Permanent prostate implant (PPI): 108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR
Outcomes
Primary Outcome Measures
Toxicity
Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
Secondary Outcome Measures
Late Toxicity
G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
High-Related Quality of Life (HRQOL)
EPIC-26 Questionnaire
PSA Complete Response (PSA-CR)
Via PSA laboratory with PSA level ≤0.3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02546427
Brief Title
Hypofractionated Whole Pelvic Radiotherapy of the Prostate
Official Title
Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI left UCSF and the study was closed without any accruals.
Study Start Date
December 9, 2016 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Albert J. Chang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have >15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if >30% acute grade 2 or >5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Step 1: Pelvic Lymph Node Irradiation
Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each
Step 2: Treat boost volume to prostate and seminal vesicles
Acceptable treatment modalities:
CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT
Permanent prostate implant (PPI):
108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR
Intervention Type
Radiation
Intervention Name(s)
Helical TomoTherapy (HT)
Intervention Type
Radiation
Intervention Name(s)
CyberKnife SBRT
Intervention Type
Radiation
Intervention Name(s)
Permanent Prostate Implant (PPI)
Intervention Type
Radiation
Intervention Name(s)
HDR brachytherapy
Primary Outcome Measure Information:
Title
Toxicity
Description
Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
Time Frame
90 days post treatment
Secondary Outcome Measure Information:
Title
Late Toxicity
Description
G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
Time Frame
From 90 days post treatment until 36 months from start of therapy
Title
High-Related Quality of Life (HRQOL)
Description
EPIC-26 Questionnaire
Time Frame
Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years.
Title
PSA Complete Response (PSA-CR)
Description
Via PSA laboratory with PSA level ≤0.3
Time Frame
120-127 days after initiation of therapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA >10, and/or Gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation.
History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
Zubrod performance status 0-2
Age ≥18 years
Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
Evidence of distant metastases
Regional lymph node involvement
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
Previous pelvic irradiation, prostate brachytherapy
Previous or concurrent cytotoxic chemotherapy for prostate cancer
Patients with history of inflammatory bowel disease or major bowel surgery.
Prior transurethral resection of the prostate (TURP) procedure.
12. IPD Sharing Statement
Learn more about this trial
Hypofractionated Whole Pelvic Radiotherapy of the Prostate
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