Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

NCT03511196 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: MCC-19367
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Stage IV Prostate Cancer; Advanced Prostate Cancer; Adenocarcinoma of the Prostate

Keywords

stage IV castration sensitive prostate cancer; advanced castration sensitive prostate cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Participant Retention

  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.

  12 months from participant's first dose of ADT

Secondary Outcomes (2)

• Median Time to Progression From the First Dose of Androgen Deprivation Therapy (ADT)

  12 months from participant's first dose of ADT

• Median Time to Radiographic Progression From the First Dose of ADT

  12 months from participant's first dose of ADT

Study Arms (1)

Adaptive ADT+ Standard of Care

EXPERIMENTAL

Participants will undergo 12-16 weeks of GnRH analog, along with 8-12 weeks of combinational therapy with GnRH analog and abiraterone plus prednisone. 14 participants who achieve \>75% PSA decline after the run-in period will be enrolled. GnRH analog and abiraterone will be stopped after study enrollment. PSA and testosterone level will be measured every 4 weeks during the run-in period, then every 6 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); Drug: Abiraterone; Drug: Prednisone

Interventions

Adaptive Androgen Deprivation Therapy (ADT) DRUG

ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.

Also known as: GnRH agonist

Adaptive ADT+ Standard of Care

Abiraterone DRUG

Prednisone 5 mg once a day with food.

Also known as: Standard of Care, Zytiga

Adaptive ADT+ Standard of Care

Prednisone DRUG

Abiraterone 1000 mg daily with empty stomach.

Also known as: Standard of Care, Glucocorticoid

Adaptive ADT+ Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• \>75% prostate specific antigen (PSA) decline after 12 to 16 weeks of run in period with Gonadotropin-releasing Hormone (GnRH) analog abiraterone plus prednisone.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
• Adequate organ function Serum alanine aminotransferase (ALT) or aspartate 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

You may not qualify if:

• Prior GnRH analog with GnRH analogue for non-metastatic prostate cancer within 12 months prior to study enrollment or \>3 months of GnRH analog in the metastatic setting
• Prior treatments with TAK-700/Orteronel, 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Zhang J, Gallaher J, Cunningham JJ, Choi JW, Ionescu F, Chatwal MS, Jain R, Kim Y, Wang L, Brown JS, Anderson AR, Gatenby RA. A Phase 1b Adaptive Androgen Deprivation Therapy Trial in Metastatic Castration Sensitive Prostate Cancer. Cancers (Basel). 2022 Oct 25;14(21):5225. doi: 10.3390/cancers14215225.

  PMID: 36358643 RESULT

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; abiraterone; Standard of Care; Abiraterone Acetate; Prednisone; Glucocorticoids

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Adrenal Cortex Hormones; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jingsong Zhang, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 27, 2018
• Study Start: September 17, 2018
• Primary Completion: June 22, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)