Prostatic NeoplasmsPhase 2NCT02560051
Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer
A Phase 2 study testing Doxorubicin, Ketoconazole and Docetaxel in people with Prostatic Neoplasms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. 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?
- Doxorubicin, Ketoconazole and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 adenocarcinoma of the prostate.
- Patients must belong to one of the following subsets:
- Prior local therapy
- Patients with Prostate Specific Antigen (PSA) recurrence following prostatectomy or radiation therapy who have no radiographic involvement. PSA doubling time ≤6 months.
- Nodal involvement only.
- Low volume bone disease: ≤3 metastases.
Show all 22Show fewer
- Nodal involvement with associated bone involvement.
- High volume bone-visceral disease: Patients with >3 metastatic bone sites or visceral metastases.
- No prior definitive local therapy
- Tumors felt to be unresectable, not candidates for radiation therapy, and PSA elevated with biopsy-proven disease.
- Metastatic disease at presentation.
- Patients may have started ADT within 3 months of study entry.
- No previous cytotoxic therapy is allowed, including systemic irradiation with strontium-89, samarium, or radium-223.
- Previous definitive radiotherapy to one metastatic site is acceptable, provided that unirradiated sites remain. At least 8 weeks must have elapsed since radiation therapy to the pelvis. Patients having limited irradiation of a metastatic site are eligible 4 weeks following radiation.
- Patients may have had previous exposure to ADT if it was given for ≤6 months to "downstage" the primary and provided that such therapy was completed at least 12 months prior to entry into this study with a return of serum testosterone to ≥200 ng/dL.
- Patients must be free of serious comorbidity and have a life expectancy of ≥3 years.
- Patients must have adequate physiologic reserves as evidenced by:
- Eastern Cooperative Oncology Group (ECOG) status of ≤2.
- Patients must have adequate bone marrow function: Platelets ≥100,000 cells/mm3, Hemoglobin ≥9.0 g/dL, and Absolute Neutrophil Count (ANC) ≥1,500 cells/mm3.
- Patients must have adequate renal function: creatinine ≤2 × upper limit of normal (ULN).
- Patients must have adequate liver function: Aspartate aminotransferase (AST) / Alanine transaminase (ALT) ≤2.5 × ULN; alkaline phosphatase <2.5 × ULN, unless bone metastasis is present in the absence of liver metastasis; and bilirubin < ULN or 1.5 mg/dl.
- No evidence of active ischemia on electrocardiogram (ECG) and documentation of ejection fraction (EF) ≥50%.
Who cannot join
- Patients must not have a second malignancy unless there is confidence of previous curative therapy.
- Patients with a recent history of transient ischemic attack (TIA) (within 6 months), who are requiring regular antianginal therapy, or who are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible
- Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
- Patients must not have sensory neuropathy > grade 1.
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: Phase 2 Study of Androgen Deprivation Therapy (ADT) Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer
This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin, Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The drugs used in this study are approved by the Food and Drug Administration (FDA).
Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the number of months they receive ADT will be based on their disease. The current standard treatment is ADT and chemotherapy. What differs in this research study is the cycling and combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side effects and are believed to provide maximum benefit.
Read the detailed description
As a working hypothesis, investigators suspect that the transformation from an androgen-dependent to an androgen-independent phenotype is mediated by expansion of an androgen-independent clone already present at the time of ADT that continues to grow while androgen-sensitive clones are being suppressed. It is thus desirable to bring treatment to bear on the androgen-independent component while the corresponding tumor burden remains minimal and prolong the time to hormone resistance. Investigators view the androgen-independent component as analogous to "microscopic residual" or "micro-metastatic" disease, for which adjuvant chemotherapy has been shown to be effective in other contexts, even when the same drugs had little or no impact on survival in the setting of more advanced disease.
By treating all components of the tumor initially, investigators anticipate that the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. Additionally, instead of treating patients empirically with an identical regimen, as in investigator's previous work, these patient subsets were designed to ensure a level of treatment appropriate to their individual disease, thus potentially lessening the burden of treatment (such as the long-term adverse effects of ADT). Investigators have chosen 3, 4, or 5 cycles of chemotherapy to be administered on the basis of tumor burden, a treatment selection method long established in germ cell tumors and used by this PI. Sub-analyses of previous data have raised the concern that treating patients with varying levels of disease the same way does not produce optimal results. Therefore, investigators seek to improve outcomes by tailoring treatment to tumor burden. In this study, patients with less tumor burden will receive 3 cycles of chemotherapy and 12 months of ADT, those with moderate tumor burden will receive 4 cycles and 18 months of treatment, and those with the greatest tumor burden will receive 5 cycles and 24 months of treatment. Additionally, this regimen of administering treatment sequentially, including a 2-week break, reduces toxicity.
- Conditions
- Prostatic Neoplasms
- Being tested
- Doxorubicin, Ketoconazole, Docetaxel, Estramustine, Degarelix
- Keywords
- Prostate Cancer, Advanced, Local Failures
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriamycin, Rubex
In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)
KetoconazoleDrug
Also called Nizoral
In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)
DocetaxelDrug
Also called Taxotere, Docecad
In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)
EstramustineDrug
Also called Emcyt
In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)
DegarelixDrug
Also called Firmagon
The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Definitive local therapy | Active comparator | 3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) Receives: Drug: Doxorubicin; Drug: Ketoconazole; Drug: Docetaxel; Drug: Estramustine; Drug: Degarelix |
| Nodal only/Low-volume bone | Active comparator | 4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Receives: Drug: Doxorubicin; Drug: Ketoconazole; Drug: Docetaxel; Drug: Estramustine; Drug: Degarelix |
| High volume/no prior tx | Active comparator | 5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Receives: Drug: Doxorubicin; Drug: Ketoconazole; Drug: Docetaxel; Drug: Estramustine; Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as Measured by Number Who Progressed
Progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements or larger/new lesion
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 10 months
Secondary outcomes (16)
Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease
Measured: about 10 months after treatment initiation
Efficacy as Measured by PSA Level
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 PSA Level
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 1 Day 1, which is the day of treatment initiation
Efficacy as Measured by PSA Level
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, which is about 8 weeks after treatment initiation
Efficacy as Measured by PSA Level
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 3 Day 1, which is about 16 weeks after treatment initiation
Efficacy as Measured by PSA Level
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 4 Day 1, which is about 24 weeks after treatment initiation
Efficacy as Measured by PSA Level
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 5 Day 1, which is about about 32 weeks after treatment initiation
Efficacy as Measured by PSA Level
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.
The time point is the end of treatment, which is about about 8 weeks after the start of the last cycle. For the arm completing 3 cycles, the time point is 24 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 32 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 40 weeks after treatment initiation.
Measured: end of treatment, which is about about 8 weeks after the start of the last cycle
Efficacy as Measured by Number Who PSA Progressed
PSA progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements
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 10 months
Quality of Life Measure by FACT-P Scale
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
Measured: post cycle 1, which is about 8 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
Measured: post cycle 2, which is about 16 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
Measured: post cycle 3, which is about 24 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
Measured: post cycle 4, which is about 32 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
Measured: post cycle 5, which is about about 40 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
The time point is about 12 weeks after completion of the last cycle. For the arm completing 3 cycles, the time point is 36 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 44 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 52 weeks after treatment initiation.
Measured: about 12 weeks after completion of the last cycle
Safety of Drug Regimen as Measured by Number of Adverse Events
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 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion12 Sep 2017
- Study completion14 Sep 2017
Why it stopped: Slow accrual; 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 Prostatic NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 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, DO, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560051
- Sponsor's protocol ID
- GU-13-101
- Other IDs
- HSC-MS-14-0949
- Status last verified
- Nov 2018
- First submitted
- 17 Sep 2015
- Last updated
- 28 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 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Androgen Deprivation Therapy (ADT) Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT02560051
- Acronym / sponsor ID
- GU-13-101
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Cancer, Advanced, Local Failures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual; resource re-allocation
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 11 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for men who have prostate cancer and have failed local therapy or are not a candidate for prostatectomy or radiation therapy. The purpose of this research study is to assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin, Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The drugs used in this study are approved by the Food and Drug Administration (FDA).
Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the number of months they receive ADT will be based on their disease. The current standard treatment is ADT and chemotherapy. What differs in this research study is the cycling and combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side effects and are believed to provide maximum benefit.
Detailed description
As a working hypothesis, investigators suspect that the transformation from an androgen-dependent to an androgen-independent phenotype is mediated by expansion of an androgen-independent clone already present at the time of ADT that continues to grow while androgen-sensitive clones are being suppressed. It is thus desirable to bring treatment to bear on the androgen-independent component while the corresponding tumor burden remains minimal and prolong the time to hormone resistance. Investigators view the androgen-independent component as analogous to "microscopic residual" or "micro-metastatic" disease, for which adjuvant chemotherapy has been shown to be effective in other contexts, even when the same drugs had little or no impact on survival in the setting of more advanced disease.
By treating all components of the tumor initially, investigators anticipate that the emergence of androgen-independent growth will be delayed, ultimately prolonging patient survival. Additionally, instead of treating patients empirically with an identical regimen, as in investigator's previous work, these patient subsets were designed to ensure a level of treatment appropriate to their individual disease, thus potentially lessening the burden of treatment (such as the long-term adverse effects of ADT). Investigators have chosen 3, 4, or 5 cycles of chemotherapy to be administered on the basis of tumor burden, a treatment selection method long established in germ cell tumors and used by this PI. Sub-analyses of previous data have raised the concern that treating patients with varying levels of disease the same way does not produce optimal results. Therefore, investigators seek to improve outcomes by tailoring treatment to tumor burden. In this study, patients with less tumor burden will receive 3 cycles of chemotherapy and 12 months of ADT, those with moderate tumor burden will receive 4 cycles and 18 months of treatment, and those with the greatest tumor burden will receive 5 cycles and 24 months of treatment. Additionally, this regimen of administering treatment sequentially, including a 2-week break, reduces toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Definitive local therapy | Active comparator | Drug: Doxorubicin, Drug: Ketoconazole, Drug: Docetaxel, Drug: Estramustine, Drug: Degarelix3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) |
| Nodal only/Low-volume bone | Active comparator | Drug: Doxorubicin, Drug: Ketoconazole, Drug: Docetaxel, Drug: Estramustine, Drug: Degarelix4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) |
| High volume/no prior tx | Active comparator | Drug: Doxorubicin, Drug: Ketoconazole, Drug: Docetaxel, Drug: Estramustine, Drug: Degarelix5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Pathologic proof of adenocarcinoma of the prostate.
- Patients must belong to one of the following subsets:
- Prior local therapy
- Patients with Prostate Specific Antigen (PSA) recurrence following prostatectomy or radiation therapy who have no radiographic involvement. PSA doubling time ≤6 months.
- Nodal involvement only.
Key exclusion criteria (4 listed)
- Patients must not have a second malignancy unless there is confidence of previous curative therapy.
- Patients with a recent history of transient ischemic attack (TIA) (within 6 months), who are requiring regular antianginal therapy, or who are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible
- Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
- Patients must not have sensory neuropathy > grade 1.
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 |
|---|---|---|
| DoxorubicinAlso: Adriamycin, RubexIn weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week) | Drug | Definitive local therapy, High volume/no prior tx, Nodal only/Low-volume bone |
| KetoconazoleAlso: NizoralIn weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) | Drug | Definitive local therapy, High volume/no prior tx, Nodal only/Low-volume bone |
| DocetaxelAlso: Taxotere, DocecadIn weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week) | Drug | Definitive local therapy, High volume/no prior tx, Nodal only/Low-volume bone |
| EstramustineAlso: EmcytIn weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) | Drug | Definitive local therapy, High volume/no prior tx, Nodal only/Low-volume bone |
| DegarelixAlso: FirmagonThe starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days | Drug | Definitive local therapy, High volume/no prior tx, Nodal only/Low-volume bone |
Primary outcome
Efficacy as Measured by Number Who Progressed
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 10 months
Progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements or larger/new lesion
16 secondary outcomes
Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease
Time frame: about 10 months after treatment initiation
Efficacy as Measured by PSA Level
Time frame: baseline
Efficacy as Measured by PSA Level
Time frame: Cycle 1 Day 1, which is the day of treatment initiation
Efficacy as Measured by PSA Level
Time frame: Cycle 2 Day 1, which is about 8 weeks after treatment initiation
Efficacy as Measured by PSA Level
Time frame: Cycle 3 Day 1, which is about 16 weeks after treatment initiation
Efficacy as Measured by PSA Level
Time frame: Cycle 4 Day 1, which is about 24 weeks after treatment initiation
Efficacy as Measured by PSA Level
Time frame: Cycle 5 Day 1, which is about about 32 weeks after treatment initiation
Efficacy as Measured by PSA Level
Time frame: end of treatment, which is about about 8 weeks after the start of the last cycle
Efficacy as Measured by Number Who PSA Progressed
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 10 months
Quality of Life Measure by FACT-P Scale
Time frame: post cycle 1, which is about 8 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
Time frame: post cycle 2, which is about 16 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
Time frame: post cycle 3, which is about 24 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
Time frame: post cycle 4, which is about 32 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
Time frame: post cycle 5, which is about about 40 weeks after treatment initiation
Quality of Life Measure by FACT-P Scale
Time frame: about 12 weeks after completion of the last cycle
Safety of Drug Regimen 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 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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, DO 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 Doxorubicin, Ketoconazole and Docetaxel in people with Prostatic Neoplasms, 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 22 inclusion and 4 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 28 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 11 Oct 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 Number Who Progressed (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 10 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 28 Nov 2018.