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

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Prolactin Release-Inhibiting Factors

Triptorelin Pamoate

Bicalutamide

Androgen Antagonists

Flutamide

Buserelin

Antineoplastic Agents, Hormonal

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Patients will receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide acetate, goserelin acetate, buserelin, or triptorelin) subcutaneously or as an injection AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily).

Patients will receive androgen-deprivation therapy as in arm I in addition to definitive treatment including surgery to remove prostate or radiation therapy to the prostate.

goserelin acetate

flutamide

leuprolide acetate

triptorelin

surgery to remove prostate or radiation therapy to the prostate.

Definitive Treatment

Ye Dingwei, MD

The goal of this clinical research is to learn if treatment with androgen deprivation therapy in combination with surgery or radiation therapy can prolong the progression-free survival of oligometastatic prostate cancer than androgen deprivation therapy alone. The safety of this treatment combination will also be studied.

Today androgen deprivation therapy has been a standard treatment for metastatic prostate cancer, but as to the special type of prostate cancer-oligometastatic prostate cancer, except for androgen deprivation therapy, whether local treatment can be the part of treatment for it? The purpose of this study is to evaluate whether local treatment combined with androgen deprivation therapy can extend progression-free survival, as well as overall survival and life quality of patients of oligometastatic prostate cancer compared with androgen deprivation therapy alone.

Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

OMPCa-Shanghai: An Open-label, Randomized Prospective Phase II Trial of Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Oligometastatic Prostate Cancer

Quality of Life assessed by the EORTC QLQ-C30 questionnaire

Fudan University

Principal Investigator

Head and Neck Neoplasms

Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer.

For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.

Biomarker analyses head & neck cancer tissue, blood specimen

Mechthild Krause, Prof.

The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.

Potential biomarkers from a previous retrospective study will be validated in this prospective study.

Objectives:

Primary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy.

Secondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer.

Outline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based.

The aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)	NCT02742675	Prostate Cancer	Bicalutamide goserelin aceta... flutamide leuprolide acet... triptorelin Definitive Trea...	18 Years - 80 Years	Fudan University
Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)	NCT02742675	Prostate Cancer	Bicalutamide goserelin aceta... flutamide leuprolide acet... triptorelin Definitive Trea...	18 Years - 80 Years	Fudan University
Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)	NCT02059668	Head and Neck C...	Biomarker analy...	18 Years -	Technische Universität Dresden

Spots Global Cancer Trial Database for definitive treatment