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Trial record 8 of 67 for:    Recruiting Studies | Prostate Cancer | Florida, United States

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03511196
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
Adaptive Androgen Deprivation Therapy (ADT) plus Standard of Care. The purpose of this study is to develop adaptive therapy for high risk metastatic castration sensitive prostate cancer (mCSPC).

Condition or disease Intervention/treatment Phase
Prostate Cancer Stage IV Prostate Cancer Advanced Prostate Cancer Adenocarcinoma of the Prostate Drug: Adaptive Androgen Deprivation Therapy (ADT) Drug: Abiraterone Drug: Prednisone Early Phase 1

Detailed Description:

Investigators proposed this pilot feasibility study to use prostate specific antigen (PSA) response and testosterone level to guide the treatment with androgen deprivation therapy (ADT) [Leuprolide, Goserelin, and Triptorelin are the most commonly used GnRH agonists for ADT] and/or abiraterone plus prednisone. Adaptive therapy is a program of chemotherapy where the type and dosage of drug changes in an attempt to kill more of the cancer.

Abiraterone acetate with prednisone is a standard of care treatment for mCRPC (metastatic castration resistant prostate cancer). It works by interrupting the male hormone (androgen) making process in the testes, adrenal glands, and tumors. This helps to prevent the growth of tumors that need these hormones to grow.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Of Intermittent Androgen Deprivation Therapy Adapted To Serum Testosterone And PSA Levels For Stage IV Castration Sensitive Prostate Cancer
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adaptive ADT+ Standard of Care
Participants will undergo 4 weeks of ADT with GnRH analog, followed by 8 weeks of combinational therapy with ADT and abiraterone plus prednisone. 14 participants who achieve >75% PSA decline after the 12 weeks of run-in period will be enrolled. ADT and abiraterone will be stopped after study enrollment. PSA and testosterone level will be measured every 2 weeks during the run-in period, then every 4 weeks after study enrollment. Imaging studies with CT and bone scan will be performed at the time of study enrollment and these will be considered baseline scans. Study treatment will be restarted if participant's PSA reaches 2 fold or higher of his baseline PSA. Selection of treatment will be based on participant's testosterone level.
Drug: Adaptive Androgen Deprivation Therapy (ADT)
ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.
Other Name: GnRH agonist

Drug: Abiraterone
Prednisone 5 mg once a day with food.
Other Names:
  • Standard of Care
  • Zytiga

Drug: Prednisone
Abiraterone 1000 mg daily with empty stomach.
Other Names:
  • Standard of Care
  • Glucocorticoid




Primary Outcome Measures :
  1. Rate of Participant Retention [ Time Frame: 12 months from participant's first dose of ADT ]
    Percentage of participants who remain on study at month 12. The study will be terminated early if 2 or more of the first 6 enrolled subjects discontinued study due to cancer progression within a year of study enrollment.


Secondary Outcome Measures :
  1. Median Time to Progression From the First Dose of Androgen Deprivation Therapy (ADT) [ Time Frame: 12 months from participant's first dose of ADT ]
    Median time to prostate specific antigen (PSA) progression while on androgen deprivation therapy (ADT), abiraterone and prednisone. Progression is per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).

  2. Median Time to Radiographic Progression From the First Dose of ADT [ Time Frame: 12 months from participant's first dose of ADT ]
    Median time to radiographic progression while on ADT, abiraterone and prednisone. Progression is per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).



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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:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • High risk mCSPC as defined by the Latitude study5 (≥ 2 of 3 risk factors: Gleason ≥ 8, ≥ 3 bone lesions, or measurable visceral metastases)
  • >75% prostate specific antigen (PSA) decline after 12 weeks of run in period with androgen deprivation therapy (ADT), abiraterone plus prednisone.
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
  • Adequate organ function Serum alanine aminotransferase (ALT) or aspirate aminotransferase (AST) must be < 2.5 x upper limit of normal (ULN), total bilirubin less than 1.5 X ULN, estimated creatinine clearance must be >40 mL/min, absolute neutrophil count (ANC) > 1500/l, hemoglobin above 9 g/dl, platelet count > 100,000/l
  • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
  • Ability to give written informed consent

Exclusion Criteria:

  • Prior ADT with GnRH analogue for non-metastatic prostate cancer within 2 years prior to study enrollment.
  • Prior treatments with TAK-700/Orteronel, abiraterone, ketoconazole, apalutamide or enzalutamide.
  • Documented central nervous system metastases or liver metastasis
  • Prior surgical castration
  • Requiring opioids for cancer related pain.
  • Treatment with any investigational compound within 30 days prior to the first dose of study drugs
  • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy & have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening period). Note: Patients may be rescreened after adjustments of antihypertensive medications
  • Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 5), New York Association Class III or IV heart failure
  • Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tables.
  • Delayed healing of wounds, ulcers, and/or bone fractures
  • Inability to comply with protocol requirements

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): NCT03511196


Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jesse Mocha    813-745-2629    jesse.mocha@moffitt.org   
Contact: Jingsong Zhang    813-745-1363    jingsong.zhang@moffitt.org   
Principal Investigator: Jingsong Zhang, M.D., Ph.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Jingsong Zhang, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03511196     History of Changes
Other Study ID Numbers: MCC-19367
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
stage IV castration sensitive prostate cancer
advanced castration sensitive prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Hypersensitivity
Genital Diseases, Male
Carcinoma
Immune System Diseases
Prednisone
Glucocorticoids
Testosterone
Androgens
Deslorelin
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action