Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Hormones

Prednisone

Satraplatin

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy

Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen

Agennix

Behaviors and Mental Disorders

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Anxiety Disorders

Depressive Disorder

Depression

Chronic Pain

Cancer Pain

Pain

Neurologic Manifestations

Quality of Life

Chronic Graft Versus Host Disease

chronic pain

Gisèle PICKERING

The aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).

This is an observational, longitudinal and multicenter study assessing in cancer patients the link between the cognitive-emotional status and the development of chronic pain.

Cognition, anxiety, depression, quality of life, social vulnerability, cancer perception, pain and analgesic consumption are assessed.

Cancer Chronic Pain Predicted by Emotional and Cognitive Status

Measure of average pain intensity by a numerical rating scale assessed 7 days before the 6 months visit after inclusion of patients.

Analgesic consumption is evaluated during all period of the study (name of the specialty, dose, indication, form, administration route, starting date, end date),

Quality of life assessment by:

- The European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), at baseline, 6 months, 12 months and 24 months. This questionnaire assesses the quality of life of cancer patients. It is divided in 9 subscales consisting of several items: 5 subscales measuring functional status (physical, role, social, emotional, cognitive), three subscales measuring symptoms (fatigue, pain, nausea and vomiting) and a global subscale of quality of life and health. Finally, six items/isolated symptoms, covering cancer symptoms and frequent side effects of cancer therapies (e.g. loss of appetite) are also included in the EORTC QLQ-C30. The EORTC QLQ-C30 Score ranges from 0 to 126

University Hospital, Clermont-Ferrand

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen	NCT00069745	Prostate Cancer Hormone Refract...	Satraplatin Prednisone	18 Years -	Agennix
Cancer Chronic Pain Predicted by Emotional and Cognitive Status	NCT02777697	Chronic Pain Cancer	chronic pain	18 Years -	University Hospital, Clermont-Ferrand

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