Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer

2014-08-27 03:14:46 | BioPortfolio


RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial.

PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well it works compared with surgery in treating patients with prostate cancer.




- Determine the proportion of patients consenting to the treatment randomization of brachytherapy vs radical prostatectomy in treating patients with good-risk prostate cancer.

- Determine the feasibility of randomization, in terms of average accrual rate per center, during the last 6 months of recruitment.


- Determine the decisional quality post-treatment in these patients.

- Determine the compliance with allocated treatment in these patients.

- Determine the clinical failure in these patients.

- Determine the PSA relapse in these patients.

- Determine the patient-reported quality of life.

- Compare the toxicity of these regimens.

OUTLINE: This is a multicenter study.

- Part 1 (decision-aid randomization): Patients are stratified according to participating center. Patients are randomized to 1 of 2 Decision-Aid arms.

- Arm I (standard patient information): Patients receive standard patient information according to routine clinical practice and preferred materials of each center. This information typically includes booklets about prostate cancer and its treatment, contact details for sources of further information (e.g., prostate support groups, prostate charities, and web-based information), and access to a specialist nurse as required.

- Arm II (standard patient information + decision aid): In addition to standard information as described in Arm I, patients are given a 30-minute Decision-Aid video or DVD to take home. The Decision Aid describes the standard treatment options available to patients, provides detailed information about treatment outcomes in relation to individual patient characteristics, and seeks to help patients apply their own personal values to their treatment decision. Patients may watch the audio-visual aid as many times as they wish.

Patients who decide to choose a treatment are removed from study; patients who agree to undergo treatment randomization proceed to part 2 of the study.

- Part 2 (treatment randomization): Patients are stratified according to risk (low risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.

- Arm I (radical prostatectomy): Patients undergo surgery within 60 days of randomization. The surgical technique for radical prostatectomy may be retropubic, transperineal, laparoscopic or robotic. Pelvic lymph node surgery is permitted at the discretion of the treating surgeon. Unilateral or bilateral nerve-sparing techniques may be used at the discretion of the treating surgeon.

- Arm II (brachytherapy): Patients undergo brachytherapy within 60 days of randomization. Brachytherapy seeds may be implanted using pre-loaded needles or a MICK® applicator of either iodine I 125 or palladium Pd 103.

Patient-reported quality-of-life data is collected to assess erectile function, urinary function, bowel function, and general quality of life at baseline and during follow up.

Patients are followed at 1 and 4 months, every 4 months for 2 years, every 6 months for 3 years, then annually for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Study Design

Allocation: Randomized, Control: Active Control, Masking: Open Label


Prostate Cancer


counseling intervention, educational intervention, quality-of-life assessment, therapeutic conventional surgery, iodine I 125, palladium Pd 103


Leeds Cancer Centre at St. James's University Hospital
United Kingdom




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:46-0400

Clinical Trials [8288 Associated Clinical Trials listed on BioPortfolio]

Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably. ...

Bilingual Breast Cancer Educational Intervention for Hispanic Women With Stage I, Stage II, or Stage III Breast Cancer and Their Families or Caregivers

RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the intermediate- and long-term effects of treatment on patients with cancer PURPOSE: This randomized...

Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer

RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate cancer and breast cancer reduce distress, make informed treatment decisions, and improve quality...

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, and Urologic Cancers

This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, and urologic c...

Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may hel...

PubMed Articles [25757 Associated PubMed Articles listed on BioPortfolio]

Participants' Experiences of a Sexual Counseling Intervention During Cardiac Rehabilitation: A Nested Qualitative Study Within the CHARMS Pilot Randomized Controlled Trial.

International guidelines recommend sexual assessment and counseling be offered to all patients with cardiovascular disease during cardiac rehabilitation. However, sexual problems are infrequently addr...

An educational intervention impact on the quality of nursing records.

to evaluate the impact of an educational intervention on the quality of nursing records.

Educational nurse-led lifestyle intervention for persons with mental illness.

Although persons with severe mental illness face an increased risk of mortality and of developing negative health outcomes, research has shown that lifestyle interventions can sufficiently support the...

A peer support intervention in improving glycemic control in patients with type 2 diabetes.

This study aims to assess the effectiveness of a peer support intervention, in which patients with T2DM were provided ongoing self-management support by trained peers with diabetes directed at improvi...

Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial.

Purpose This study aimed to test a group psychosocial intervention focused on improving disturbances of body image (BI), sexual functioning, and quality of life in breast cancer (BC) survivors. Method...

Medical and Biotech [MESH] Definitions

A study in which observations are made before and after an intervention, both in a group that receives the intervention and in a control group that does not.

A study that uses observations at multiple time points before and after an intervention (the "interruption"), in an attempt to detect whether the intervention has had an effect significantly greater than any underlying trend over time.

An organized and comprehensive program of health care that identifies and reduces a woman's reproductive risks before conception through risk assessment, health promotion, and interventions. Preconception care programs may be designed to include the male partner in providing counseling and educational information in preparation for fatherhood, such as genetic counseling and testing, financial and family planning, etc. This concept is different from PRENATAL CARE, which occurs during pregnancy.

The sum total of nursing activities which includes assessment (identifying needs), intervention (ministering to needs), and evaluation (validating the effectiveness of the help given).

The use of severity-of-illness measures, such as age, to estimate the risk (measurable or predictable chance of loss, injury or death) to which a patient is subject before receiving some health care intervention. This adjustment allows comparison of performance and quality across organizations, practitioners, and communities. (from JCAHO, Lexikon, 1994)

More From BioPortfolio on "Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer"

Quick Search


Relevant Topic

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...

Searches Linking to this Trial