Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

NCTNCT02560051Other idGU-13-101Other idHSC-MS-14-0949

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Slow accrual; resource re-allocation

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 19 participants (actual)
Sponsor: The University of Texas Health Science Center, Houston · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2015
Primary completion: 12 Sept 2017
Completion: 14 Sept 2017
First posted: 25 Sept 2015 (estimated)
Last update posted: 28 Nov 2018
Conditions: Prostatic Neoplasms

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2015201620172018

Ph 2
Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer
NCT02560051
Nov 2015 to 14 Sept 2017
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

DoxorubicinDrug
KetoconazoleDrug
DocetaxelDrug
EstramustineDrug
DegarelixDrug

Arms3

Active comparator
Definitive local therapy
3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix)
Active comparator
Nodal only/Low-volume bone
4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix)
Active comparator
High volume/no prior tx
5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix)

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Progression defined as increase in Prostate Specific Antigen (PSA) \>0.3 ng/mL over 2 measurements or larger/new lesion

Secondary outcomes(16)

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
Registry description
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.
Efficacy as Measured by PSA Level
Time frame · Cycle 1 Day 1, which is the day of treatment initiation
Registry description
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.
Efficacy as Measured by PSA Level
Time frame · Cycle 2 Day 1, which is about 8 weeks after treatment initiation
Registry description
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.
Efficacy as Measured by PSA Level
Time frame · Cycle 3 Day 1, which is about 16 weeks after treatment initiation
Registry description
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.
Efficacy as Measured by PSA Level
Time frame · Cycle 4 Day 1, which is about 24 weeks after treatment initiation
Registry description
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.
Efficacy as Measured by PSA Level
Time frame · Cycle 5 Day 1, which is about about 32 weeks after treatment initiation
Registry description
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.
Efficacy as Measured by PSA Level
Time frame · end of treatment, which is about about 8 weeks after the start of the last cycle
Registry description
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.
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
Registry description
PSA progression defined as increase in Prostate Specific Antigen (PSA) \>0.3 ng/mL over 2 measurements
Quality of Life Measure by FACT-P Scale
Time frame · post cycle 1, which is about 8 weeks after treatment initiation
Registry description
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.
Quality of Life Measure by FACT-P Scale
Time frame · post cycle 2, which is about 16 weeks after treatment initiation
Registry description
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.
Quality of Life Measure by FACT-P Scale
Time frame · post cycle 3, which is about 24 weeks after treatment initiation
Registry description
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.
Quality of Life Measure by FACT-P Scale
Time frame · post cycle 4, which is about 32 weeks after treatment initiation
Registry description
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.
Quality of Life Measure by FACT-P Scale
Time frame · post cycle 5, which is about about 40 weeks after treatment initiation
Registry description
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.
Quality of Life Measure by FACT-P Scale
Time frame · about 12 weeks after completion of the last cycle
Registry description
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.
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 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

Efficacy as Measured by Number Who Progressed

Group	Value (Participants)
Definitive Local Therapy	0
Nodal Only/Low-volume Bone	0
High Volume/no Prior tx	2

Secondary and other outcome results(7)

Secondary outcomeCount of participants· about 10 months after treatment initiation

Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease

Group	Value (Participants)
Definitive Local Therapy	0
Nodal Only/Low-volume Bone	3
High Volume/no Prior tx	3

Secondary outcomeMedian· baseline

Efficacy as Measured by PSA Level

Group	Value (ng/mL)
Definitive Local Therapy	5.7
Nodal Only/Low-volume Bone	15.8
High Volume/no Prior tx	90.7

Secondary outcomeMedian· Cycle 1 Day 1, which is the day of treatment initiation

Efficacy as Measured by PSA Level

Group	Value (ng/mL)
Definitive Local Therapy	5.7
Nodal Only/Low-volume Bone	9.7
High Volume/no Prior tx	90.7

Secondary outcomeMedian· Cycle 2 Day 1, which is about 8 weeks after treatment initiation

Efficacy as Measured by PSA Level

Group	Value (ng/mL)
Definitive Local Therapy	0.01
Nodal Only/Low-volume Bone	0.3
High Volume/no Prior tx	3.8

Secondary outcomeMedian· Cycle 3 Day 1, which is about 16 weeks after treatment initiation

Efficacy as Measured by PSA Level

Group	Value (ng/mL)
Definitive Local Therapy	0.01
Nodal Only/Low-volume Bone	0.1
High Volume/no Prior tx	0.9

Secondary outcomeMedian· Cycle 4 Day 1, which is about 24 weeks after treatment initiation

Efficacy as Measured by PSA Level

Group	Value (ng/mL)
Definitive Local Therapy	not posted
Nodal Only/Low-volume Bone	0.01
High Volume/no Prior tx	0.55

Secondary outcomeMedian· Cycle 5 Day 1, which is about about 32 weeks after treatment initiation

Efficacy as Measured by PSA Level

Group	Value (ng/mL)
Definitive Local Therapy	not posted
Nodal Only/Low-volume Bone	not posted
High Volume/no Prior tx	0.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Definitive Local Therapy3 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 12 months ADT (degarelix) Doxorubicin: 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) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: 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) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: 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	0 / 6	3 / 6	6 / 6
Nodal Only/Low-volume Bone4 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 18 months ADT (degarelix) Doxorubicin: 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) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: 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) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: 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	0 / 8	2 / 8	8 / 8
High Volume/no Prior tx5 cycles of chemotherapy (doxorubicin, ketoconazole, docetaxel and estramustine) + 24 months ADT (degarelix) Doxorubicin: 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) Ketoconazole: In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days) Docetaxel: 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) Estramustine: In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days) Degarelix: 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	0 / 5	0 / 5	5 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: * 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. * 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%. Exclusion criteria: * 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.

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