Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

NCTNCT02494713 (opens ClinicalTrials.gov in a new tab)Other idGU-14-101Other idHSC-MS-14-0424
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
4 participants (actual)
Sponsor
The University of Texas Health Science Center, Houston · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2015
Primary completion
14 Sept 2017
Completion
14 Sept 2017
First posted
10 Jul 2015 (estimated)
Last update posted
27 Nov 2018
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 2

    Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

    NCT02494713

    Oct 2015 to 14 Sept 2017

    Terminated

Registry summary

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

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.

Interventions

  • DegarelixDrug
  • DoxorubicinDrug
  • KetoconazoleDrug
  • DocetaxelDrug
  • EstramustineDrug

Arms1

  • Other

    ADT + chemotherapy

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy as Measured by Pathologic Response

    Time frame · Day of prostate removal, which is about 5 months following the day participant signed consent.

    Registry description

    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.

Secondary outcomes(13)

  1. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    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.

  2. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy)

    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.

  3. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy)

    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.

  4. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · Day 133, about 19 weeks after treatment initiation (but before prostatectomy)

    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.

  5. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · about 20 weeks after treatment initiation (day of prostatectomy)

    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.

  6. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · about 32 weeks after treatment initiation (about 12 weeks after prostatectomy)

    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.

  7. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · about 44 weeks after treatment initiation (about 24 weeks after prostatectomy)

    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.

  8. Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

    Time frame · about 68 weeks after treatment initiation (about 48 weeks after prostatectomy)

    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.

  9. 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.

  10. Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)

    Time frame · baseline

    Registry description

    The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.

  11. 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)

    Registry description

    The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.

  12. 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.

    Registry description

    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.

  13. 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

    Registry description

    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

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 outcomeMedian· Day of prostate removal, which is about 5 months following the day participant signed consent.

Efficacy as Measured by Pathologic Response

GroupValue (percentage of tumor burden remaining)
ADT + Chemotherapy30
Secondary and other outcome results(7)
Secondary outcomeMedian· baseline

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy58.7
Secondary outcomeMedian· Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy)

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy0.4
Secondary outcomeMedian· Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy)

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy0.15
Secondary outcomeMedian· Day 133, about 19 weeks after treatment initiation (but before prostatectomy)

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy0.055
Secondary outcomeMedian· about 20 weeks after treatment initiation (day of prostatectomy)

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy0.01
Secondary outcomeMedian· about 32 weeks after treatment initiation (about 12 weeks after prostatectomy)

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy0.01
Secondary outcomeMedian· about 44 weeks after treatment initiation (about 24 weeks after prostatectomy)

Efficacy as Measured by Prostate-specific Antigen (PSA) Levels

GroupValue (ng/mL)
ADT + Chemotherapy0.35

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ADT + ChemotherapyPatients 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. Degarelix: Subcutaneous injection, once/month for 4 months Doxorubicin: 20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5 Ketoconazole: 400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5 Docetaxel: 35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6 Estramustine: 280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 60 / 40 / 44 / 4

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 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 * 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. Exclusion Criteria: * 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. * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.