Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03358563|
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Docetaxel Drug: Degarelix Drug: Bicalutamide||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
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
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
- 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.
- 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.
- PSA Recurrence [ Time Frame: Up to 12 months ]Rate of patients with PSA recurrence at month 12 after surgery
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
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
|Contact: Cancer Connectfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cancer Connect 800-622-8922 email@example.com|
|Principal Investigator: Christos Kyriakopoulos, MD|
|Principal Investigator:||Christos Kyriakopoulos, MD||University of Wisconsin, Madison|