Prostatic NeoplasmsPhase 1/2PET PRONCT02004418
A Study for Patients With Prostate Cancer to See Whether Delivering an Extra Dose of Radiation to Parts of the Body With More Cancer is Better Than Standard Treatment in Which the Same Dose of Radiation is Given Throughout the Prostate Gland
A Phase 1/2 study testing 11C-Choline in people with Prostatic Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Patients with localized prostate cancer are routinely treated with radiation therapy to the entire prostate gland. The investigators can identify where the cancer is concentrated in the prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for choline positron emission tomography). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- 11C-Choline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Sep 2020
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years
- Biopsy proven prostate cancer with an intermediate risk feature defined as
- Gleason score 7, PSA <20, T1-T2C or
- Gleason score 6, PSA 10-20, T1-T2C or
- Gleason Score 6 or 7, PSA <20, T2C
- Localized disease based on staging investigations including bone scan, CT abdomen and pelvis, and any other clinically indicated staging investigations
Show all 10Show fewer
- Eligible for curative intent external beam radiotherapy
- Able and willing to follow instructions and comply with protocol
- Provide written informed consent prior to participation in the study
- Karnofsky Performance Scale Score 70-100
Who cannot join
- Have had a 11C-Choline PET scan performed within 4 weeks after any biopsies of the prostate (due to concern that acute post biopsy intraprostatic changes may affect scan accuracy)
- BMI ≥ 30
- The presence of a hip prosthesis
- Bilirubin ≥ 20 µmol/L
- AST or ALT ≥ 5 times the upper limits of normal
- Serious medical conditions which may prevent a patient from tolerating therapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections and/or uncontrolled diabetes.
Show all 14Show fewer
- Metastatic disease
- Prostate cancer with only low risk features or any high risk feature with a PSA ≥20 or T3 disease
- A history of previous carcinoma except for basal cell carcinoma
- Age < 18 years
- Prior treatment with hormonal therapy
- AUA prostate symptom score > 20
- Crohn's disease or ulcerative colitis
- Patient is unable to comply adequately iwth bowel or bladder prep during CT simulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Predictive Factor for Biochemical Disease-Free Survival in Patients With Localized Prostate Cancer
Patients with localized prostate cancer are routinely treated with radiation therapy to the entire prostate gland. The investigators can identify where the cancer is concentrated in the prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for choline positron emission tomography). This is different from the older type of PET scan that has been used in the past (called FDG PET) which has not been as accurate as the new PET scan for identifying where the cancer is in the prostate gland. It has also been shown that delivering higher doses of radiation to prostate cancer cells in the prostate have resulted in better cure rates in patients with prostate cancer. Therefore for goal number one the investigators want to give higher radiation dose to the prostate cancer cells. But the challenge has been that delivering higher doses of radiation to the prostate gland may also increase the chance of complications from the higher doses of radiation to the rectum, bladder and surrounding area. Therefore for goal number two the investigators want to minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla Magnetic Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to identify the urethra in the prostate so that the investigators can minimize the radiation dose to the urethra. The investigators believe the 3T MRI scan is able to point to the areas of cancer that may be able to predict how well the treatments may work, as well as which areas of the tumor appear to be responding to failing.
In this study, the investigators will keep the dose of radiation to the rectum and bladder as low as possible while increasing radiation dose to parts of the prostate with more cancer cells. The investigators will compare the cure rates in this study with the cure rates of other patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland. The investigators will also compare the rates of complications in this study with the rates of complications in patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland.
Read the detailed description
This is a prospective, open label, non-randomized, single site, phase I/II study of the safety and utility of 11C-Choline PET scans for delineation of intraprostatic lesions in subjects with localized intermediate risk prostate cancer and subsequent Enhanced EBRT (External Beam Radiation Therapy) to monitor toxicity, therapeutic response and recurrence.
The estimated total number of subjects required for protocol enrollment and baseline 11C-Choline PET scans is 63; however, the protocol will complete accrual only when 29 subjects have commenced Enhanced EBRT or the outlined stopping rules require a halt to accrual. Twenty-nine (29) subjects treated with Enhanced EBRT are required to assess the toxicity of this treatment based on the statistical analysis outlined in the protocol. Subjects will receive a fixed dose (400 MBq, 10%) of 11C-Choline and PET/CT imaging with co-registration 3T MRI imaging prior to Enhanced EBRT and two further doses of 11C-Choline at two intervals (3 and 6 months) thereafter.
Subjects with suitable intraprostatic lesion delineation with 11C-Choline will proceed to Enhanced EBRT, consisting of a dose prescription of 78 Gy in 25 fractions to the intraprostatic lesions and 68 Gy in 25 fractions (simultaneously) to the prostate gland. Subjects without suitable intraprostatic lesion delineation will be treated with Cross Cancer Institute standard of care EBRT and undergo follow-up for biochemical recurrence per protocol to determine the prognostic value of the baseline PET findings.
Subjects will be monitored for 11C-Choline safety and efficacy and for EBRT safety / toxicity and efficacy.
11C-Choline PET image intraprostatic lesion(s) will be analyzed by the relative uptake scores (RUS), tumor to background ratios (T/B) and SUVmax parameters. Adequate delineation will be determined by a lesion with tumor to background ration ≥2. This is defined in section 10.
11C-Choline PET image parameters will be correlated with other measures of progression and survival including biochemical disease free survival as indicators of Enhanced EBRT response.
Efficacy of 11C-Choline delineated Enhanced EBRT will be evaluated by progression and survival analysis compared to historical data from this population.
Safety of 11C-Choline will be determined by: vital signs, blood hematology and clinical biochemistry profile (pre-injection, post-imaging) and adverse event collection.
Safety/toxicity of 11C-Choline delineated Enhanced EBRT will be determined by adverse event collection, primarily for genitourinary and gastrointestinal toxicity and compared to historical data from this population.
- Conditions
- Prostatic Neoplasms
- Being tested
- 11C-Choline
- Keywords
- C-Choline PET scans, external beam radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-CholineRadiation
| Study group | Role | What they receive |
|---|---|---|
| C-Choline PET Scans | Experimental | Radioactive doses of 11C-Choline: 400 MBq ± 10% per injection, pre-radiation treatment and following treatment at 3 and 6 months Receives: Radiation: 11C-Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT.
Measured: After 3 months
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
Measured: After 3 years
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
Measured: After 5 years
Secondary outcomes (2)
Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
Measured: 3 months
Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive a fixed dose (400 MBq +/-10%) of 11C-Choline and PET/CT imaging with co-registration 3T MRI imaging prior to Enhanced EBRT and two further doses of 11C-Choline at two intervals (3 and 6 months) thereafter. Subjects with suitable intraprostatic lesion delineation with 11C-Choline will proceed to Enhanced EBRT, consisting of a dose prescription of 78 Gy in 25 fractions to the intraprostatic lesions and 68 Gy in 25 fractions (simultaneously) to the prostate gland. Subjects without suitable intraprostatic lesion delineation will be treated with Cross Cancer Institute standard of care EBRT and undergo follow-up for biochemical recurrence per protocol to determine the prognostic value of the baseline PET findings
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Amanie, MD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004418
- Sponsor's protocol ID
- CCI-Amanie-02 (PET PRO)
- Acronym
- PET PRO
- Status last verified
- Jan 2021
- First submitted
- 15 Nov 2013
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Predictive Factor for Biochemical Disease-Free Survival in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02004418
- Acronym / sponsor ID
- PET PRO / CCI-Amanie-02 (PET PRO)
- Conditions
- Prostatic Neoplasms
- Keywords
- C-Choline PET scans, external beam radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 9 Dec 2013 (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.
Patients with localized prostate cancer are routinely treated with radiation therapy to the entire prostate gland. The investigators can identify where the cancer is concentrated in the prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for choline positron emission tomography). This is different from the older type of PET scan that has been used in the past (called FDG PET) which has not been as accurate as the new PET scan for identifying where the cancer is in the prostate gland. It has also been shown that delivering higher doses of radiation to prostate cancer cells in the prostate have resulted in better cure rates in patients with prostate cancer. Therefore for goal number one the investigators want to give higher radiation dose to the prostate cancer cells. But the challenge has been that delivering higher doses of radiation to the prostate gland may also increase the chance of complications from the higher doses of radiation to the rectum, bladder and surrounding area. Therefore for goal number two the investigators want to minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla Magnetic Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to identify the urethra in the prostate so that the investigators can minimize the radiation dose to the urethra. The investigators believe the 3T MRI scan is able to point to the areas of cancer that may be able to predict how well the treatments may work, as well as which areas of the tumor appear to be responding to failing.
In this study, the investigators will keep the dose of radiation to the rectum and bladder as low as possible while increasing radiation dose to parts of the prostate with more cancer cells. The investigators will compare the cure rates in this study with the cure rates of other patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland. The investigators will also compare the rates of complications in this study with the rates of complications in patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland.
Detailed description
This is a prospective, open label, non-randomized, single site, phase I/II study of the safety and utility of 11C-Choline PET scans for delineation of intraprostatic lesions in subjects with localized intermediate risk prostate cancer and subsequent Enhanced EBRT (External Beam Radiation Therapy) to monitor toxicity, therapeutic response and recurrence.
The estimated total number of subjects required for protocol enrollment and baseline 11C-Choline PET scans is 63; however, the protocol will complete accrual only when 29 subjects have commenced Enhanced EBRT or the outlined stopping rules require a halt to accrual. Twenty-nine (29) subjects treated with Enhanced EBRT are required to assess the toxicity of this treatment based on the statistical analysis outlined in the protocol. Subjects will receive a fixed dose (400 MBq, 10%) of 11C-Choline and PET/CT imaging with co-registration 3T MRI imaging prior to Enhanced EBRT and two further doses of 11C-Choline at two intervals (3 and 6 months) thereafter.
Subjects with suitable intraprostatic lesion delineation with 11C-Choline will proceed to Enhanced EBRT, consisting of a dose prescription of 78 Gy in 25 fractions to the intraprostatic lesions and 68 Gy in 25 fractions (simultaneously) to the prostate gland. Subjects without suitable intraprostatic lesion delineation will be treated with Cross Cancer Institute standard of care EBRT and undergo follow-up for biochemical recurrence per protocol to determine the prognostic value of the baseline PET findings.
Subjects will be monitored for 11C-Choline safety and efficacy and for EBRT safety / toxicity and efficacy.
11C-Choline PET image intraprostatic lesion(s) will be analyzed by the relative uptake scores (RUS), tumor to background ratios (T/B) and SUVmax parameters. Adequate delineation will be determined by a lesion with tumor to background ration ≥2. This is defined in section 10.
11C-Choline PET image parameters will be correlated with other measures of progression and survival including biochemical disease free survival as indicators of Enhanced EBRT response.
Efficacy of 11C-Choline delineated Enhanced EBRT will be evaluated by progression and survival analysis compared to historical data from this population.
Safety of 11C-Choline will be determined by: vital signs, blood hematology and clinical biochemistry profile (pre-injection, post-imaging) and adverse event collection.
Safety/toxicity of 11C-Choline delineated Enhanced EBRT will be determined by adverse event collection, primarily for genitourinary and gastrointestinal toxicity and compared to historical data from this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive a fixed dose (400 MBq +/-10%) of 11C-Choline and PET/CT imaging with co-registration 3T MRI imaging prior to Enhanced EBRT and two further doses of 11C-Choline at two intervals (3 and 6 months) thereafter. Subjects with suitable intraprostatic lesion delineation with 11C-Choline will proceed to Enhanced EBRT, consisting of a dose prescription of 78 Gy in 25 fractions to the intraprostatic lesions and 68 Gy in 25 fractions (simultaneously) to the prostate gland. Subjects without suitable intraprostatic lesion delineation will be treated with Cross Cancer Institute standard of care EBRT and undergo follow-up for biochemical recurrence per protocol to determine the prognostic value of the baseline PET findings
| Arm | Type | Receives |
|---|---|---|
| C-Choline PET Scans | Experimental | Radiation: 11C-CholineRadioactive doses of 11C-Choline: 400 MBq ± 10% per injection, pre-radiation treatment and following treatment at 3 and 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Biopsy proven prostate cancer with an intermediate risk feature defined as
- Localized disease based on staging investigations including bone scan, CT abdomen and pelvis, and any other clinically indicated staging investigations
- Eligible for curative intent external beam radiotherapy
- Able and willing to follow instructions and comply with protocol
Key exclusion criteria (14 listed)
- Have had a 11C-Choline PET scan performed within 4 weeks after any biopsies of the prostate (due to concern that acute post biopsy intraprostatic changes may affect scan accuracy)
- BMI ≥ 30
- The presence of a hip prosthesis
- Bilirubin ≥ 20 µmol/L
- AST or ALT ≥ 5 times the upper limits of normal
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 |
|---|---|---|
| 11C-Choline | Radiation | C-Choline PET Scans |
Primary outcome
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT.
Time frame: After 3 months
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
Time frame: After 3 years
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
Time frame: After 5 years
2 secondary outcomes
Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
Time frame: 3 months
Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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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.
John Amanie, MD principal investigator
Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 11C-Choline in people with Prostatic Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
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 10 inclusion and 14 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: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT. (time frame: After 3 months). The study lists 3 primary outcomes in all. 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 1 Feb 2021.