Efficacy Study Evaluating Chemotherapy in Prostate Cancer

NCT01978873 | Unknown Phase 3 DMC

• 2 other identifiers: 2011-0030-78-102011-003078-10
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) the ability to identify subjects at high risk of dying early from their disease, 2) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel that can improve survival in subjects with advanced disease and 4) that chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time to progression. It is the investigators hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment. This trial will determine whether any benefit is gained by adding chemotherapy before hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or high risk disease.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of randomization until date of death from any cause, assessed up to 7 years.

Secondary Outcomes (2)

• Progression free survival

  From date of randomization until progression, assessed up to 3 years.

• PSA response

  From date of randomization up to 7 years.

Study Arms (2)

Arm A:

EXPERIMENTAL

* Cabazitaxel 25 mg / m² / day on day 1 every 3 weeks continued if the patient has stable disease or responding to up to 10 cycles. Cabazitaxel will be administered in combination with oral prednisone or prednisolone (Prednisolon 10mg 1x1) * Hormones will be initiated in conjunction with the last cycle of chemotherapy. Consists of the administration of a luteinizing hormone-releasing hormone (LHRH) agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device. G-CSF treatment according to ASCO guidelines is recommended.

Drug: Cabazitaxel + Androgen deprivation therapy

Arm B:

ACTIVE COMPARATOR

-Hormone: LHRH agonist antiandrogens for 30 days + OR surgical castration OR CAB complete androgen blockade by LHRH agonist + antiandrogen device.

Drug: Androgen deprivation therapy

Interventions

Cabazitaxel + Androgen deprivation therapy DRUG

Cabazitaxel + LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.

Also known as: Jevtana-Leuporelin

Arm A:

Androgen deprivation therapy DRUG

LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.

Also known as: Leuporelin

Arm B:

Eligibility Criteria

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

You may qualify if:

• Histological or cytological confirmed prostate adenocarcinoma Metastatic PC (Prostate cancer) with measurable or evaluable disease or High risk PC (PSA \> 100) or Node positive disease (N+)
• No prior treatment for prostate cancer (including bisfosfonate)
• Age above 18 years
• ECOG 0- 2
• Estimated survival \> 3 months
• WBC 2000 / mm 3, neutrophils ≥1500 / mm 3, platelets 100,000 / mm 3
• Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal.
• Satisfactory renal function. Serum creatinine \<1.5 x ULN (150 mmol/l). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \>60 mL/min are accepted in the study. https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr
• Patient information and signature of informed consent

You may not qualify if:

• Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)
• Severe peripheral neuropathy
• Active infection or other serious underlying pathology that could prevent patients from receiving treatment
• Brain metastases, uncontrolled symptomatic or asymptomatic
• Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization.
• Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
• Systemic treatment with high dose steroids
• Any severe acute or chronic medical condition which would impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

University Hospital of Örebro

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; Androgen Antagonists

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)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ove Andrén, Ass Prof.

  University Hospital Örebro

  PRINCIPAL INVESTIGATOR

• Marie Hjelm-Eriksson, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associated professor

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)