Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Hormones

Questionnaires taking 20 minutes to complete.

Questionnaire

Deborah A. Kuban, MD

The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.

Questionnaires:

You will complete 2 questionnaires that will ask you questions about your quality of life, urinary, bowel, sexual function, and any side effects that you may be having. You will be asked about any medications you may be taking and any other medical conditions you may have. The questionnaires will take about 20 minutes to complete. You may complete the questionnaires at the clinic, have them mailed to you (return postage will be included), or be asked the questions over the phone.

If you are on active surveillance (checking for prostate cancer by routine blood draws and biopsy, without active treatment), you will fill out the questionnaires on the same schedule as those receiving treatment that does not involve hormones.

If you are receiving therapy that does not involve hormones, you will complete the questionnaires before you receive treatment.

If you are receiving hormone therapy, you will complete the questionnaires before beginning the hormone therapy and then again within 3 weeks before starting radiation.

For all participants, at 3 and 6 months after the treatment is completed, you will complete the questionnaires again. Starting 6 months after you finish treatment, you will complete the questionnaires every 6 months for 2 years. Starting 2 years after treatment, you will complete the questionnaires once a year for 3 years.

Length of Study:

All participants will be considered off-study once they have completed the last questionnaires. You will be taken off study early if you receive a second treatment for prostate cancer or if you decide to have treatment while on active surveillance.

This is an investigational study. Up to 1448 patients will be enrolled in this study. All will be enrolled at MD Anderson, MD Anderson Albuquerque, and MD Anderson Cooper.

Quality of Life Study for Prostate Cancer Patients

A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients

M.D. Anderson Cancer Center

The surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh.surgery started with dissection of the pelvic lymph nodes. If there were no signs of metastasis in frozen sections, the operation was continued with retropubic radical prostatectomy. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing.The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying.

External beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line.

The surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing. Pelvic lymph node dissection is performed if feasible. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying.

Radical retropubic prostatectomy

External beam radiotherapy

Savino M. Di Stasi, MD, PhD

The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.

Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.

Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer

Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. The definition of biochemical recurrence was based on a review of the literature and consideration of clinical practice in the year 1997. Biochemical recurrence among patients who underwent radical prostatectomy (RP) was defined as a measurable serum PSA concentration 0.2 ng/ml or greater. The American Society for Therapeutic Radiology and Oncology (ASTRO) criteria were used to define progression after radiation therapy. The ASTRO consensus definition specifies progression as 3 consecutive increases in serum PSA documented at intervals of 6 or more months.

The Medical Outcomes Study 36-Item Short Form (SF-36) version 2 contains 36 items covering eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. For each dimension, a score ranges from 0-100 (higher score indicate better health).Physical and mental component summaries are constructed, using recommended scoring algorithms. Summary scores are standardized to have a mean of 50 and standard deviation of 10 in the general population.

The Functional Assessment of Cancer Therapy - General (FACT-G) version 4.0 was designed to measure Quality of Life in cancer patients. It consists of 27 items in 4 dimensions measuring Physical, Social/familial, Emotional, and Functional well-being. The Prostate module (FACT-P) is specific for patients with prostate cancer and contains 12 questions about urinary symptoms, and bowel and sexual function. Scores range from 0 to 108 on the FACT-G, and from 0 to 48 on the FACT-P, with 0 representing perfect health.

The International Prostate Symptom Score (IPSS) was developed to assess the severity of lower urinary tract symptoms associated to Benign Prostatic Hyperplasia and has also been applied to other conditions that cause lower urinary tract symptoms (LUTS). The IPSS consists of a total of seven questions that deal with voiding symptoms (incomplete empty, intermittency, weak stream and straining to void) and storage symptoms (frequency, urgency and nocturia) and an additional question to measure quality of life. The score ranges from 0 to 35, with lower scores denoting a better health state.

The International Index of Erectile Function (IIES) is a 15-item, self-administered questionnaire scale for the assessment of erectile function. Scores range from 5 to 75, with higher scores denoting a better sexual function.

Number of participants who are alive after a specified duration of time.

Number of participants who are not dead due to prostate cancer after a specified duration of time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality of Life Study for Prostate Cancer Patients	NCT00561444	Prostate Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer	NCT02091661	Prostate Cancer	Radical retropu... External beam r...	- 75 Years	University of Rome Tor Vergata
Quality of Life Study for Prostate Cancer Patients	NCT00561444	Prostate Cancer	Questionnaire	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for radical retropubic prostatectomy