Advertisement

Topics

Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

2016-02-03 17:53:22 | BioPortfolio

Summary

This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

Description

PRIMARY OBJECTIVE:

I. Demonstrate that prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) of patients with "unfavorable" intermediate-risk or "favorable" high-risk prostate cancer compared to NADT and high-dose prostate and seminal vesicle (SV) radiation therapy (prostate [P] + SV radiation therapy [RT]) using intensity-modulated radiotherapy (IMRT) or external-beam RT (EBRT) with a high-dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.

SECONDARY OBJECTIVES:

I. Demonstrate that prophylactic WPRT improves biochemical control. II. Distant metastasis (DM)-free survival. III. Cause-specific survival (CSS). IV. Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT + P and SV RT.

V. Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT). (closed to patient accrual 3/9/15) VI. Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (Patient-Reported Outcome Measurement Information System [PROMIS] Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (interleukin [IL]-1, IL-1 receptor antagonist [ra], IL-6, tumor necrosis factor [TNF]-alpha, and C-reactive protein). (closed to patient accrual 3/9/15) VII. Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). (closed to patient accrual 3/9/15) VIII. Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.

IX. Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily (QD) or flutamide PO thrice daily (TID) for 6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 6 or 32 months. Radiotherapy begins within 8-10 weeks after beginning LHRH agonist/antagonist injection.

ARM I: Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using IMRT* or 3D-conformal radiation therapy (3D-CRT)* QD, 5 days a week, for approximately 9 weeks. Patients may also undergo PPI brachytherapy or high-dose rate brachytherapy (iodine I 125 or palladium Pd 103 may be used as the radioisotope).

ARM II: Patients undergo WPRT* (3D-CRT or IMRT) QD, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in Arm I.

NOTE: * Patients undergoing brachytherapy implant receive 5 weeks of IMRT, 3D-CRT, or WPRT.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Adenocarcinoma

Intervention

3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Selective External Radiation Therapy

Location

University of South Alabama Mitchell Cancer Institute
Mobile
Alabama
United States
36688

Status

Recruiting

Source

Radiation Therapy Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-02-03T17:53:22-0500

Clinical Trials [5408 Associated Clinical Trials listed on BioPortfolio]

Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cel...

PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells....

Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

RATIONALE: Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Specialized radiation therapy that delivers a high dose of radiation d...

Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer

RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing ...

Intensity Modulated Radiation Therapy - Prostate Cancer

There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for...

PubMed Articles [19614 Associated PubMed Articles listed on BioPortfolio]

Salivary flow rate after conventional and intensity-modulated radiation therapy.

Conventional 3-dimensional conformal radiation therapy (3DCRT) for head and neck cancer (HNC) can cause hyposalivation, leading to caries and tooth extraction-related osteoradionecrosis. Intensity-mod...

Intensity-modulated radiation therapy (IMRT) versus 3-dimensional conformal radiation therapy (3D-CRT) for head and neck cancer: cost-effectiveness analysis.

A cost-effectiveness analysis of IMRT compared to 3D-CRT for head and neck cancer patients (HNCPs) was conducted in the Brazilian Public Health System.

Systematic review and meta-analyses of intensity-modulated radiation therapy versus conventional two-dimensional and/or or three-dimensional radiotherapy in curative-intent management of head and neck squamous cell carcinoma.

Technological advancements in treatment planning and delivery have propelled the use of intensity-modulated radiation therapy (IMRT) in head and neck squamous cell carcinoma (HNSCC). This review compa...

Patterns of Local-Regional Failure after Intensity-Modulated Radiation Therapy or Passive Scattering Proton Therapy with Concurrent Chemotherapy for Non-Small Cell Lung Cancer.

We compared differences in patterns of local-regional failure, and the influence of adaptive planning on those patterns, in patients given passive scattering proton therapy (PSPT) vs. intensity-modula...

The opportunities of computer simulation training in radiation therapy.

The use of computer simulation is arguably more widespread in other industries than in medicine. However, it has filtered into mainstream use in radiation therapy via a commercial product born from co...

Medical and Biotech [MESH] Definitions

CONFORMAL RADIOTHERAPY that combines several intensity-modulated beams to provide improved dose homogeneity and highly conformal dose distributions.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.

Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.

A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.

More From BioPortfolio on "Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...


Searches Linking to this Trial