Prostate CancerPhase 2NCT02494713
Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer
A Phase 2 study testing Degarelix, Doxorubicin and Ketoconazole in people with Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. 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?
- Degarelix, Doxorubicin and Ketoconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 14 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3. No neuroendocrine differentiation or small cell features.
- Recent (<6 weeks prior to study entry) negative bone scan and CT of the chest and abdomen.
- Appropriate surgical candidate for radical prostatectomy and a performance status of <2 (ECOG scale).
- Adequate bone marrow function as defined as an absolute peripheral granulocyte count >1500 and platelet count >100,000.
- Adequate hepatic function per the following criteria:
- Albumin ≥2.8 g/dL
Show all 13Show fewer
- AST and ALT ≤5 x ULN
- Total bilirubin <2 mg/dL
- Adequate renal function per the following criteria:
- o Serum creatinine ≤1.5 x ULN
- Normal coagulation profile (INR ≤ 1.5, aPTT ≤ 1.5 x ULN for the lab) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
- Age ≥ 18 years
- Written informed consent to participate in this study.
Who cannot join
- Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features
- Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first ADT and chemotherapy treatment
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or investigational study drug.
- Unable to tolerate multiparametric MRI or is contraindicated.
- Patients not appropriate surgical candidates for radical prostatectomy based on the evaluation of coexistent medical diseases and competing causes of death.
- Patients with uncontrolled cardiac, hepatic, renal, or neurologic/psychiatric disorder.
Show all 13Show fewer
- Severe gastrointestinal bleeding within 12 weeks of treatment with ADT and chemotherapy
- Patients who are HIV positive or have chronic hepatitis B or C infections.
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a 2D echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months of enrollment demonstrates a left ventricular ejection fraction >45%.
- Sensory neuropathy grade >1.
- History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer.
- Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment.
- Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
UTHealth Memorial Hermann Cancer Center
Houston, Texas, 77030
About this study
Official title: Neoadjuvant Androgen Deprivation Therapy and Chemotherapy Followed by Radical Prostatectomy in Patients With Prostate Cancer
This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.
Read the detailed description
This is an open-label, single-arm study of neoadjuvant ADT and chemotherapy in subjects with non-metastatic, locally-advanced prostate cancer who are eligible for radical prostatectomy.
Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy. Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.
The primary endpoint will be complete or near-complete pathologic response.
Safety will be assessed on any patient receiving at least one dose of study drug by the reporting of adverse events, vital signs and by the assessment of findings on physical exam and routine safety laboratory determinations. The severity of adverse events and certain abnormal laboratory findings will be assessed according to the NCI CTCAE V4.03.
Laboratory-based studies will evaluate the following:
- Complete metabolic profile
- BUN, creatinine, alkaline phosphatase, ALT/AST, total bilirubin, LDH, calcium, albumin, glucose, magnesium, uric acid, phosphorous
- Electrolytes
- Sodium, potassium, chloride, CO2 content
- Hematology
- CBC with differential, platelet count
- PT, INR, PTT
- Testosterone
- Biomarkers
- PSA
- CTCs
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Doxorubicin, Ketoconazole, Docetaxel, Estramustine
- Keywords
- Advanced Prostate Cancer, Neoadjuvant, Hormone therapy, ADT, Androgen Deprivation Therapy, Chemotherapy, Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Also called Firmagon, degarelix acetate
Subcutaneous injection, once/month for 4 months
DoxorubicinDrug
Also called Adriamycin
20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5
KetoconazoleDrug
Also called Nizoral
400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5
DocetaxelDrug
Also called Taxotere
35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6
EstramustineDrug
Also called Emcyt
280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
| Study group | Role | What they receive |
|---|---|---|
| ADT + chemotherapy | Other | Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. Receives: Drug: Degarelix; Drug: Doxorubicin; Drug: Ketoconazole; Drug: Docetaxel; Drug: Estramustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as Measured by Pathologic Response
Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate.
Measured: Day of prostate removal, which is about 5 months following the day participant signed consent.
Secondary outcomes (13)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: baseline
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: Day 133, about 19 weeks after treatment initiation (but before prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: about 20 weeks after treatment initiation (day of prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: about 32 weeks after treatment initiation (about 12 weeks after prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: about 44 weeks after treatment initiation (about 24 weeks after prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: about 68 weeks after treatment initiation (about 48 weeks after prostatectomy)
Efficacy as Measured by Circulating Tumor Cell (CTC) Numbers
Measured: From the time the participant signs the informed consent until prostatectomy, an average of 5 months.
Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)
The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.
Measured: baseline
Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)
The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.
Measured: post treatment but prior to prostatectomy (about 25 days after the end of treatment)
Safety of Drug Regimen as Measured by Number of Adverse Events
Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.
Measured: From the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.
Surgical Morbidity as Measured by Number of Adverse Events
Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until the participant was taken off-study or the study was stopped, an average of 20 months
Measured: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startOct 2015
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Why it stopped: slow enrollment; resource re-allocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert J Amato, The University of Texas Health Science Center, Houston
- Investigators
- Robert J Amato, D.O., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494713
- Sponsor's protocol ID
- GU-14-101
- Other IDs
- HSC-MS-14-0424
- Status last verified
- Nov 2018
- First submitted
- 23 Jun 2015
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Androgen Deprivation Therapy and Chemotherapy Followed by Radical Prostatectomy in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT02494713
- Acronym / sponsor ID
- GU-14-101
- Conditions
- Prostate Cancer
- Keywords
- Advanced Prostate Cancer, Neoadjuvant, Hormone therapy, ADT, Androgen Deprivation Therapy, Chemotherapy, Radical Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment; resource re-allocation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 27 Nov 2018
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 study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.
Detailed description
This is an open-label, single-arm study of neoadjuvant ADT and chemotherapy in subjects with non-metastatic, locally-advanced prostate cancer who are eligible for radical prostatectomy.
Patients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy. Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy.
The primary endpoint will be complete or near-complete pathologic response.
Safety will be assessed on any patient receiving at least one dose of study drug by the reporting of adverse events, vital signs and by the assessment of findings on physical exam and routine safety laboratory determinations. The severity of adverse events and certain abnormal laboratory findings will be assessed according to the NCI CTCAE V4.03.
Laboratory-based studies will evaluate the following:
- Complete metabolic profile
- BUN, creatinine, alkaline phosphatase, ALT/AST, total bilirubin, LDH, calcium, albumin, glucose, magnesium, uric acid, phosphorous
- Electrolytes
- Sodium, potassium, chloride, CO2 content
- Hematology
- CBC with differential, platelet count
- PT, INR, PTT
- Testosterone
- Biomarkers
- PSA
- CTCs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADT + chemotherapy | Other | Drug: Degarelix, Drug: Doxorubicin, Drug: Ketoconazole, Drug: Docetaxel, Drug: EstramustinePatients will be treated with 4 monthly injections of degarelix along with two 8-week cycles of chemotherapy (doxorubicin and ketoconazole, weeks 1, 3, 5 and docetaxel and estramustine, weeks 2, 4, 6). Each cycle of chemotherapy will consist of 6 weeks of chemotherapy and 2 weeks of rest. In the absence of toxicity or disease progression, patients will receive 2 cycles of treatment prior to radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3. No neuroendocrine differentiation or small cell features.
- Recent (<6 weeks prior to study entry) negative bone scan and CT of the chest and abdomen.
- Appropriate surgical candidate for radical prostatectomy and a performance status of <2 (ECOG scale).
- Adequate bone marrow function as defined as an absolute peripheral granulocyte count >1500 and platelet count >100,000.
- Adequate hepatic function per the following criteria:
Key exclusion criteria (13 listed)
- Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features
- Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first ADT and chemotherapy treatment
- Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or investigational study drug.
- Unable to tolerate multiparametric MRI or is contraindicated.
- Patients not appropriate surgical candidates for radical prostatectomy based on the evaluation of coexistent medical diseases and competing causes of death.
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 |
|---|---|---|
| DegarelixAlso: Firmagon, degarelix acetateSubcutaneous injection, once/month for 4 months | Drug | ADT + chemotherapy |
| DoxorubicinAlso: Adriamycin20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 | Drug | ADT + chemotherapy |
| KetoconazoleAlso: Nizoral400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 | Drug | ADT + chemotherapy |
| DocetaxelAlso: Taxotere35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 | Drug | ADT + chemotherapy |
| EstramustineAlso: Emcyt280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6 | Drug | ADT + chemotherapy |
Primary outcome
Efficacy as Measured by Pathologic Response
Time frame: Day of prostate removal, which is about 5 months following the day participant signed consent.
Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate.
13 secondary outcomes
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: baseline
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: Day 133, about 19 weeks after treatment initiation (but before prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: about 20 weeks after treatment initiation (day of prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: about 32 weeks after treatment initiation (about 12 weeks after prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: about 44 weeks after treatment initiation (about 24 weeks after prostatectomy)
Efficacy as Measured by Prostate-specific Antigen (PSA) Levels
Time frame: about 68 weeks after treatment initiation (about 48 weeks after prostatectomy)
Efficacy as Measured by Circulating Tumor Cell (CTC) Numbers
Time frame: From the time the participant signs the informed consent until prostatectomy, an average of 5 months.
Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)
Time frame: baseline
Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)
Time frame: post treatment but prior to prostatectomy (about 25 days after the end of treatment)
Safety of Drug Regimen as Measured by Number of Adverse Events
Time frame: From the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.
Surgical Morbidity as Measured by Number of Adverse Events
Time frame: From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert J Amato, D.O. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Degarelix, Doxorubicin and Ketoconazole in people with Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Nov 2018. 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 United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 27 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy as Measured by Pathologic Response (time frame: Day of prostate removal, which is about 5 months following the day participant signed consent.). 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 27 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.