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Trial record 58 of 2746 for:    prostate cancer AND Cancer | ( Map: United States )

Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03358563
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
United States Department of Defense
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA response, time to PSA recurrence and safety and toxicity of the combination. This study will be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as well in the bone marrow before and after treatment and will also include imaging analyses using a novel positron emission tomography (PET) imaging technology.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Degarelix Drug: Bicalutamide Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Neoadjuvant Trial of Chemohormonal Therapy Followed by Prostatectomy in Patients With High Risk or Oligometastatic Prostate Cancer
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Degarelix SC + bicalutamide + docetaxel
Degarelix SC monthly x3 + bicalutamide 50mg orally QD x 14 wks + Docetaxel 75mg/m2 IV q 21 days x 3
Drug: Docetaxel
Docetaxel is a commercially marketed product that has been approved by the FDA for the treatment of metastatic prostate cancer. It is also approved for the treatment of other malignant disease, such as locally advanced or metastatic breast cancer that returns after any prior chemotherapy; locally advanced or metastatic non-small cell lung cancer that recurs after prior platinum-based chemotherapy. However, the FDA does not currently approve its use in patients with localized prostate cancer but no evidence of radiographic metastases.
Other Names:
  • docetaxel chemotherapy
  • taxotere
  • PR 56976
  • NSC #628503

Drug: Degarelix
Degarelix is a leuteinizing hormone-releasing hormone (LHRH) antagonist. Degarelix is administered at an initial dose of 240 mg subcutaneously (2 separate injections of 120mg each totaling 240 mg) two weeks prior to cycle 1 day 's 1 treatment with chemotherapy. The initial dose is followed by a maintenance dose of 80mg administered subcutaneously as a single injection every 28 days at cycle 2 day 1 (+/- 7 days) and cycle 3 day 10 (+/- 7 days)
Other Name: Degarelix acetate

Drug: Bicalutamide
The dose for bicalutamide tablets therapy in combination with an LHRH analog (in this study, degarelix) is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide tablets be taken at the same time each day. Treatment with bicalutamide tablets should be started at the same time as treatment with an LHRH analog.
Other Name: Casodex




Primary Outcome Measures :
  1. Change in pCR rates [ Time Frame: Up to 6 months ]
    Evaluate the pathologic complete response (pCR) rates in the primary tumor from patients with newly diagnosed locally advanced or oligometastatic prostate cancer treated with combination androgen deprivation therapy (ADT) and 3 cycles of docetaxel chemotherapy followed by prostatectomy.


Secondary Outcome Measures :
  1. Change in PSA [ Time Frame: From baseline (3 months prior to prostatectomy) to 6 weeks after prostatectomy. ]
    Evaluate the percentage of change in prostate-specific antigen (PSA) from baseline (3 months prior to prostatectomy) to week 6 after prostatectomy in patients with newly diagnosed locally advanced or oligometastatic prostate cancer treated with combination ADT and docetaxel as well as the maximum decline in PSA that occurs at any point during treatment.

  2. PSA Recurrence [ Time Frame: Up to 12 months ]
    Rate of patients with PSA recurrence at month 12 after surgery

  3. Safety and tolerability of combination ADT and docetaxel measured by CTCAE v.4.0 [ Time Frame: Up to 6 months ]
    Evaluate safety and tolerability of the combination of ADT and docetaxel for up to three months following the last dose of docetaxel.


Other Outcome Measures:
  1. Evaluating PSMA PET/MRI imaging [ Time Frame: Up to 12 months ]
    Evaluate PSMA PET/MRI imaging as a method for determining treatment response in primary prostate cancer and metastatic lesions after ADT and docetaxel.

  2. Evaluating Response Heterogeneity [ Time Frame: Up to 6 months ]
    Evaluate heterogeneity of response in multifocal prostate lesions at the time the primary objective is assessed

  3. Change in total tumor burden in individual lesions [ Time Frame: Up to 12 months ]
    Evaluate change in total tumor burden in individual lesions and across all lesions over time for each patient

  4. Disease progression [ Time Frame: Up to 12 months ]
    Correlate disease progression on MRI, technetium Tc 99m medronate (99mTc-MDP) bone scintigraphy and CT scans with PSMA uptake measures

  5. PSMA PET results and PSA response correlation [ Time Frame: Up to 12 months ]
    Correlate prostate-specific membrane antigen (PSMA) PET results with PSA response and time to PSA progression

  6. Evaluate genomic signatures in multifocal prostate cancer after ADT and Docetaxel [ Time Frame: Up to 12 months ]
    Prostate cancer cells extracted from the prostatectomy specimen will undergo nucleic acid extraction. DNA will be isolated and sequenced using the Foundation Medicine Next Generation Sequencing platform or other genomic panels

  7. Evaluate gene expression signatures in multifocal prostate cancer after ADT and Docetaxel [ Time Frame: Up to 12 months ]
    Prostate cancer cells will be extracted from the prostatectomy specimen and undergo nucleic acid extraction. mRNA will be isolated and analyzed with gene expression panels with quantitative RT PCR and/or next generation sequencing.

  8. Evaluate gene expression signatures in prostate stroma after ADT and Docetaxel [ Time Frame: Up to 12 months ]
    Prostate stromal cells will be extracted from the prostatectomy specimen and undergo nucleic acid extraction. mRNA will be isolated and analyzed with gene expression panels with quantitative RT PCR and/or next generation sequencing.

  9. Evaluate infiltrating immune cells in prostatectomy specimens after ADT and Docetaxel [ Time Frame: Up to 12 months ]
    Immune cells will be extracted from the prostatectomy specimen and bone marry biopsies. These cells are labelled with antibodies and quantified using flow cytometry.

  10. Evaluating EpCAM-positive disseminated and circulating tumor cells [ Time Frame: Up to 12 months ]
    Evaluate epithelial cell adhesion molecule (EpCAM)-positive disseminated and circulating tumor cells for subcellular localization of the androgen receptor and glucocorticoid receptor

  11. Disseminated and circulating tumor cell analyses versus PSMA PET/MRI and clinical outcomes [ Time Frame: Up to 12 months ]
    Correlate disseminated and circulating tumor cell analyses with the PSMA PET/MRI measures and clinical outcomes.

  12. Evaluate immune microenvironment in bone marrow after ADT and Docetaxel [ Time Frame: Up to 12 months ]
    Immune cells will be extracted from the prostatectomy specimen and bone marrow biopsies.

  13. Evaluate secretory profile of stroma after ADT and Docetaxel [ Time Frame: Up to 12 months ]
    Prostate stromal cells will be extracted from the prostatectomy specimen and undergo nucleic acid extraction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evaluate safety and tolerability of the combination of ADT and docetaxel for up to three months following the last dose of docetaxel.
  • High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA >20 ng/mL or Gleason score of 8 to 10 and/or regional lymph node or
  • Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes that meet the following criteria:

    • No visceral metastases
    • Less than four bony metastases.
  • Ability to comply with all study procedures and willingness to remain supine for 120 minutes during imaging.
  • Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
  • Patients must be considered candidates for prostatectomy as per standard of care.
  • Adequate hematologic and renal function as evidenced by the following within 4 weeks of day 1:

    • ANC >1500/mm3
    • Hemoglobin (HgB) >10.0 gr/dL independent of transfusion
    • Platelets >100,000/mm3
    • Creatinine <2.0 mg/dL
    • Total bilirubin < Upper Limit of Normal (ULN)
  • Estimated life expectancy of ≥ 12 months at screening.
  • Throughout the study, patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after last dose of study drug. Two acceptable methods of birth control thus include the following:

    • A condom (barrier method of contraception) AND One of the following is required:
    • Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner
    • Placement of an intrauterine device or intrauterine system by the female partner
    • Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
    • Tubal ligation in the female partner performed at least 6 months before screening
    • Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), performed at least 6 months before screening
  • While receiving chemotherapy, the patient must use a condom if having sex with a pregnant woman.
  • Must agree not to donate sperm from first dose of study drug through 3 months after the last dose of study drug.

Exclusion Criteria:

  • Prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide.
  • Prior radiation to the prostate.
  • Use of other investigational agent for prostate cancer.
  • No active secondary malignancy
  • Chronic liver disease or abnormal liver function:

    • Total bilirubin >ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is >ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
    • Alanine (ALT) or aspartate (AST) aminotransferase >2.0 x ULN or
    • ALT or aspartate AST >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN.
  • Peripheral neuropathy grade >1.
  • Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous 6 months.
  • Major surgery within 4 weeks before screening.
  • Patients with known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
  • Herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. Saw Palmetto) are not allowed while on study.
  • Subjects may not be enrolled concurrently on other treatment studies.
  • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator or medical monitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358563


Contacts
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Contact: Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    800-622-8922    cancerconnect@uwcarbone.wisc.edu   
Principal Investigator: Christos Kyriakopoulos, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
United States Department of Defense
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christos Kyriakopoulos, MD University of Wisconsin, Madison

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03358563     History of Changes
Other Study ID Numbers: UW17009
P30CA014520 ( U.S. NIH Grant/Contract )
2017-0606 ( Other Identifier: Institutional Review Board )
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Prostate Cancer
Prostatectomy
Chemohormonal therapy
Androgen deprivation therapy
docetaxel chemotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Docetaxel
Bicalutamide
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs