Prostate CancerNCT02546427
Hypofractionated Whole Pelvic Radiotherapy of the Prostate
A study testing Helical TomoTherapy (HT), CyberKnife SBRT and Permanent Prostate Implant (PPI) in people with Prostate Cancer, run by Albert J. Chang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Helical TomoTherapy (HT), CyberKnife SBRT and Permanent Prostate Implant (PPI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2016to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Helical TomoTherapy (HT), CyberKnife SBRT, Permanent Prostate Implant (PPI), HDR brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helical TomoTherapy (HT)Radiation
CyberKnife SBRTRadiation
Permanent Prostate Implant (PPI)Radiation
HDR brachytherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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 Receives: Radiation: Helical TomoTherapy (HT); Radiation: CyberKnife SBRT; Radiation: Permanent Prostate Implant (PPI); Radiation: HDR brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
Measured: 90 days post treatment
Secondary outcomes (3)
Late Toxicity
G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
Measured: From 90 days post treatment until 36 months from start of therapy
High-Related Quality of Life (HRQOL)
EPIC-26 Questionnaire
Measured: Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years.
PSA Complete Response (PSA-CR)
Via PSA laboratory with PSA level ≤0.3
Measured: 120-127 days after initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study start9 Dec 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: PI left UCSF and the study was closed without any accruals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert J. Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albert J. Chang, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546427
- Sponsor's protocol ID
- 15551
- Status last verified
- Feb 2018
- First submitted
- 27 Aug 2015
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02546427
- Acronym / sponsor ID
- 15551
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left UCSF and the study was closed without any accruals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert J. ChangUniversity, hospital or other
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Helical TomoTherapy (HT), Radiation: CyberKnife SBRT, Radiation: Permanent Prostate Implant (PPI), Radiation: HDR brachytherapyStep 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helical TomoTherapy (HT) | Radiation | Treatment |
| CyberKnife SBRT | Radiation | Treatment |
| Permanent Prostate Implant (PPI) | Radiation | Treatment |
| HDR brachytherapy | Radiation | Treatment |
Primary outcome
Toxicity
Time frame: 90 days post treatment
Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
3 secondary outcomes
Late Toxicity
Time frame: From 90 days post treatment until 36 months from start of therapy
High-Related Quality of Life (HRQOL)
Time frame: Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years.
PSA Complete Response (PSA-CR)
Time frame: 120-127 days after initiation of therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Helical TomoTherapy (HT), CyberKnife SBRT and Permanent Prostate Implant (PPI) in people with Prostate Cancer, run by Albert J. Chang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (time frame: 90 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.