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

Group-based behavioral workshop to address cancer-related distress

group-based behavioral workshop to address cancer-related distress

Acceptance and Commitment Therapy

Niloofar Afari, PhD

Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.

Acceptance-Based Treatment for Prostate Cancer Distress

Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans

Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who drop out of the active treatment arm.

Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who refuse the active treatment arm.

Alliant International University

University of California, San Diego

Veterans Medical Research Foundation

All Drugs and Chemicals

Dutasteride

5-alpha Reductase Inhibitors

Enzyme Inhibitors

Hormones

Hormone Antagonists

The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.

The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.

Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.

The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.

Placebo

Al Barqawi, MD

The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.

This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

A Randomized Placebo-Controlled Double-Blind Clinical Trial to Assess the Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.

GlaxoSmithKline

University of Colorado, Denver

Adverse events were monitored throughout the course of the study and 3-months as a follow up period.

Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.

This group received a placebo followed by 3D mapping biopsy.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

A one sided test of proportions with an alpha level of 0.025 was performed for a conservative Fisher's exact method. It was estimated that an 80% power in a test of proportions with 100 men in each arm would detect a 17% difference in proportion of men with increased tumor volume (upstaging) between the treatment arm and the control arm.

This study was terminated due to low accrual.

Dr. Al Baha Barqawi

"The study was terminated. Study end points were not reached. No data were collected

To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Acceptance-Based Treatment for Prostate Cancer Distress	NCT01594593	Early Stage Pro...	Acceptance and ...	18 Years - 80 Years	Veterans Medical Research Foundation
Acceptance-Based Treatment for Prostate Cancer Distress	NCT01594593	Early Stage Pro...	Acceptance and ...	18 Years - 80 Years	Veterans Medical Research Foundation
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer	NCT00985738	Prostate Cancer	Dutasteride Placebo	40 Years - 85 Years	University of Colorado, Denver
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer	NCT00985738	Prostate Cancer	Dutasteride Placebo	40 Years - 85 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for early stage prostate cancer