Prostatic NeoplasmsPhase 1NCT02631616
Treatment With Sandostatin in Patients With Castrate Resistance Prostate Cancer Showing Uptake of 68Ga-DOTATET
A Phase 1 study testing Somatostatin in people with Prostatic Neoplasms, run by Hadassah Medical Organization.
Trial summary
Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of neuroendocrine differentiation (NED). Recently the investigators initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with CRPC. 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?
- Somatostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Mar 2018
- Phase
- Phase 1
- 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
- Patients with histologically proven prostate cancer.
- Hormonal treatment (either surgical orchiectomy or medical castration with LHRH agonist or antagonist).
- Proven castration levels (serum Testosterone< 50 ng/dl)
- Radiological evidence of metastatic disease.
- Uptake of the radiotracer 68Ga-DOTATET in at two least to metastases.
Who cannot join
- 1. Participation in another trial.
About this study
Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of neuroendocrine differentiation (NED). Recently the investigators initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found. It has been shown that monthly injections of Somatostatin lengthen overall survival in patients with NET. The purpose of the current project is to examine the ability of Somatostatin to stabilize or possibly reverse metastases in patients with CRPC that express high level of somatostatin receptors in 68Ga-DOTATET PET/CT.
Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT. Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will be considered eligible for the study. These patients will be evaluated biochemically and clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical, biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months of treatment. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.
Read the detailed description
Introduction: Neuroendocrine tumors (NET) present receptors to somatostatin. This feature is utilized therapeutically in patients with metastatic NET. Monthly injection of Somatostatin was shown to lengthen overall survival (compared to placebo) in these patients. From histological studies it is known that advanced prostate cancer often shows neuroendocrine differentiation (NED). This is considered one of the mechanisms of "escape" of tumor cells from androgen deprivation therapy. Recently the investigatros initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with castrate resistance prostate cancer. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found.
Purpose: The purpose of the current project is to examine the ability of LAR Somatostatin to stabilize or possibly reverse metastases in patients with castrate resistance prostate cancer that express high level of somatostatin receptors.
The aims of the study are:
- To detect biochemical response (PSA and chromogranin A)
- To detect PET response (in repeated PET/CT, 68Ga-DOTATET).
- To detect clinical response (QOL 30 questioner).
- To detect adverse response.
Materials and Methods:
- Eligible patients will be evaluated by: serum levels of PSA, chromogranin A, Pro GRP and possibly other non-genetic markers and by QOL 30 questioner
- Treatment with monthly injections of Sandoatatin LAR - 30mg will be initiated.
- Evaluation will be done after 4 injections and will include: blood tests for PSA and chromogranin A, Pro GRP and possibly other non-genetic markers and by QOL 30 questioner and by PET/CT with 68Ga-DOTATET. Similar evaluation will be done after 12 injections. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.
- Conditions
- Prostatic Neoplasms
- Being tested
- Somatostatin
- Keywords
- Prostatic Neoplasma, Castration-Resistant, neuroendocrine differentiation, 68Ga-DOTATET, PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Also called Sandoatatin LAR - 30mg
Monthly injections of Somatostatin
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Monthly injections of Somatostatin (Sandoatatin LAR - 30mg) Receives: Drug: Somatostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
QOL 30 questioner
Measured: 4 months
Secondary outcomes (2)
Biochemical response
Blood test for PSA (in ng/ml)
Measured: 4 months
Imaging response
PET/CT with 68Ga-DOTATET
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2018 (estimated)
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.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ofer Gofrit, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631616
- Sponsor's protocol ID
- NEPros-HMO-CTIL
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Sandostatin in Patients With Castrate Resistance Prostate Cancer Showing Uptake of 68Ga-DOTATET
- ClinicalTrials.gov ID
- NCT02631616
- Acronym / sponsor ID
- NEPros-HMO-CTIL
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic Neoplasma, Castration-Resistant, neuroendocrine differentiation, 68Ga-DOTATET, PET/CT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 16 Dec 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.
Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of neuroendocrine differentiation (NED). Recently the investigators initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found. It has been shown that monthly injections of Somatostatin lengthen overall survival in patients with NET. The purpose of the current project is to examine the ability of Somatostatin to stabilize or possibly reverse metastases in patients with CRPC that express high level of somatostatin receptors in 68Ga-DOTATET PET/CT.
Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT. Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will be considered eligible for the study. These patients will be evaluated biochemically and clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical, biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months of treatment. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.
Detailed description
Introduction: Neuroendocrine tumors (NET) present receptors to somatostatin. This feature is utilized therapeutically in patients with metastatic NET. Monthly injection of Somatostatin was shown to lengthen overall survival (compared to placebo) in these patients. From histological studies it is known that advanced prostate cancer often shows neuroendocrine differentiation (NED). This is considered one of the mechanisms of "escape" of tumor cells from androgen deprivation therapy. Recently the investigatros initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with castrate resistance prostate cancer. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found.
Purpose: The purpose of the current project is to examine the ability of LAR Somatostatin to stabilize or possibly reverse metastases in patients with castrate resistance prostate cancer that express high level of somatostatin receptors.
The aims of the study are:
- To detect biochemical response (PSA and chromogranin A)
- To detect PET response (in repeated PET/CT, 68Ga-DOTATET).
- To detect clinical response (QOL 30 questioner).
- To detect adverse response.
Materials and Methods:
- Eligible patients will be evaluated by: serum levels of PSA, chromogranin A, Pro GRP and possibly other non-genetic markers and by QOL 30 questioner
- Treatment with monthly injections of Sandoatatin LAR - 30mg will be initiated.
- Evaluation will be done after 4 injections and will include: blood tests for PSA and chromogranin A, Pro GRP and possibly other non-genetic markers and by QOL 30 questioner and by PET/CT with 68Ga-DOTATET. Similar evaluation will be done after 12 injections. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: SomatostatinMonthly injections of Somatostatin (Sandoatatin LAR - 30mg) |
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)
- Patients with histologically proven prostate cancer.
- Hormonal treatment (either surgical orchiectomy or medical castration with LHRH agonist or antagonist).
- Proven castration levels (serum Testosterone< 50 ng/dl)
- Radiological evidence of metastatic disease.
- Uptake of the radiotracer 68Ga-DOTATET in at two least to metastases.
Key exclusion criteria (1 listed)
- 1. Participation in another trial.
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 |
|---|---|---|
| SomatostatinAlso: Sandoatatin LAR - 30mgMonthly injections of Somatostatin | Drug | Treatment arm |
Primary outcome
Clinical response
Time frame: 4 months
QOL 30 questioner
2 secondary outcomes
Biochemical response
Time frame: 4 months
Imaging response
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Individual participant dataSharing planned: Undecided
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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 Phase 1 study testing Somatostatin in people with Prostatic Neoplasms, run by Hadassah Medical Organization.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Dec 2015. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Clinical response (time frame: 4 months). 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 16 Dec 2015.