louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00536653: Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer
Official title: Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: prostate cancer
bone density
osteoporosis
androgen antagonists
Lead sponsor: Wirral University Teaching Hospital NHS Trust
Sponsor class: OTHER
First posted: 2007-09-28
Enrollment: 618
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

Detailed description: Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.

Eligibility criteria: Inclusion Criteria:

* Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Patients with any illness or medication that would affect bone and mineral metabolism
* Severe hepatic or renal insufficiency

Primary outcomes:
measure: Peripheral Forearm bone mineral density
timeFrame: Over 7 years
Secondary outcomes:
measure: Fractures of the thoracolumbar spine
timeFrame: Over 7 years
Other outcomes:
Locations:
city: Upton, Wirral
country: United Kingdom
facility: Wirral University Hospitals NHS Trust
state: Merseyside
Study officials:
affiliation: Wirral University Hospitals NHS Trust
name: Nigel J Parr, MBBS, FRCS(Urol), MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04172753: Feasibility of Online MR-guided Radiotherapy on a 1.5T MR-Linac
Official title: Feasibility of Imaging and Radiotherapy on a Novel 1.5 T Hybrid Magnetic Resonance Imaging - Linear Accelerator System (MR-Linac)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Head and Neck Cancer
Liver Cancer
Breast Cancer
Prostate Cancer
Oligometastasis
Esophageal Cancer
Keywords: Radiotherapy
Adaptive Radiotherapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates the feasibility of imaging and treatment on a novel 1.5 T MR-Linac radiotherapy hybrid device.

Detailed description: Novel hybrid devices combine magnetic resonance imaging (MRI) and a linear accelerator in a single device. The superior soft tissue contrast compared with cone-beam computed tomography based treatment and the possibility for daily plan adaptation promise a higher precision of treatment, better target volume coverage and normal tissue sparing. In a first step the present study will test the feasibility of imaging and treatment on the 1.5 T MR-Linac.

Eligibility criteria: Inclusion Criteria:

* existing indication for radiation therapy
* minimum age 18 years, no upper age limit
* capacity for consent
* Informed consent

Exclusion Criteria:

* contraindication for MRI (claustrophobia, metallic implants not applicable for MRI
* pregnancy

Primary outcomes:
measure: Feasibility of online MR guided Radiotherapy
timeFrame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)
Secondary outcomes:
measure: Time analysis
timeFrame: During every single patients treatment (i.e. between one to seven weeks after the first application of radiotherapy)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Radiation Oncology
state: Baden-Württemberg
Study officials:
References: