A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone

NCT03211052 | Terminated Phase 2 DMC

• 1 other identifier: 008285QM
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates neoadjuvant TAK-700 orteronel for 6 months prior to prostatectomy. The three year biochemical free survival is the primary endpoint. There are a number of 2nd endpoints such as pathological complete response rate, the need for adjuvant radiation therapy, use of post operative radiotherapy an the rate of positive margins at surgery. Translational endpoints include measuring tumoural and plasma testosterone as well as other androgens. Patients with untreated high risk and intermediate risk operable prostate cancer will be treated with TAK-700 (plus LHRH agonist) for 24 weeks prior to planned prostatectomy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 3 year biochemical progression free survival (PSA)

  Post-operative serum PSA of greater or equal to 0.2 ng/dl on 2 separate occasions as defined by the AUA.

  3 years

Study Arms (2)

TAK-700 + LHRH agonist + Prostatectomy

EXPERIMENTAL

Neoadjuvant TAK-700 for 6 months with LHRH agonists prior to prostatectomy

Drug: TAK-700 and LHRH agonist

Prostatectomy

OTHER

Prostatectomy only-Within 28 days of randomisation

Procedure: prostatectomy

Interventions

TAK-700 and LHRH agonist DRUG

TAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy

Also known as: Orteronel (TAK 700), LHRH-Leuprorelin Acetate

TAK-700 + LHRH agonist + Prostatectomy

prostatectomy PROCEDURE

SURGICAL REMOVAL OF THE PROSTATE

Prostatectomy

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent
• No previous treatment for prostate cancer (including surgery, any hormone therapy, radiotherapy, cryotherapy).
• Age ≥ 18 years and male
• Histologically or cytologically confirmed adenocarcinoma of the prostate with Gleason score. A prostate biopsy within 6 months from screening is allowed for entry requirements.
• Intermediate or high risk prostate cancer according to National Comprehensive Cancer Network (NCCN) risk stratification criteria
• Intermediate: PSA \>10 \& \<20 or a Gleason score 7 or clinical stage up to and including T2c disease
• High risk: PSA\>20 or Gleason 8-10 or clinical stage \>T2c
• Serum testosterone \> 200 ng/dL
• Prostatectomy is the planned treatment option.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate organ function, defined as follows:
• Hemoglobin \>10.0g/dL
• Absolute neutrophil count \> 1.5 x 10.9/L
• Platelet count \>100 x 10.9/L
• AST and /or ALT \<2.5 x ULN

You may not qualify if:

• Serious co-existent medical conditions such as chronic active autoimmune disease, (within the last 6 months) or infection (such as hepatitis).
• Uncontrolled hypertension within the screening period (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed to enrol provided blood pressure is controlled by anti-hypertensive therapy.
• Patients taking regular oral steroids for any reason.
• Previously treated prostate cancer (including radiotherapy, hormone therapy or surgery).
• History of pituitary or adrenal dysfunction
• Other active malignancy over the last 5 years that has required systemic therapy excluding:
• Adjuvant therapy in the curative setting
• Non-melanoma skin cancer
• Superficial transitional cell carcinoma (CIS-T1).
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
• Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Day 1
• Not willing to comply with the procedural requirements of this protocol, including repeat prostate biopsies
• Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 16 weeks after last study drug administration.
• Uncontrolled diabetes mellitus, in the opinion of the treating physician
• Known hypersensitivity to compounds related to TAK-700 or to TAK-700 excipients.

Sponsors & Collaborators

• Centre of Experimental Medicine: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

orteronel; Gonadotropin-Releasing Hormone; Prostatectomy

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; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Thomas Powles

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: July 7, 2017
• Study Start: February 18, 2013
• Primary Completion: June 2, 2015
• Study Completion: June 2, 2015
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

GB (1)