Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer

NCT02168062 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 135513NCI-2015-01058
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot partially-randomized phase II trial studies how well Supportive Therapy in Androgen Deprivation (STAND) clinic works in improving health outcomes and managing side effects in patients with prostate cancer. Individualized counseling regarding exercise and dietary habits may help improve patient understanding, satisfaction, and overall lessen adverse impact on quality of life caused by androgen deprivation.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Absolute Change in Percentage Body Fat Mass as Measured by Bioelectrical Impedance Analyzer (Randomized Cohort)

  The absolute change from baseline in percentage body fat after 12 months of study participation for participants in the randomized cohort was measured using a bioelectrical impedance analyzer and between group comparisons were performed using the Wilcoxon-rank-sum test.

  Up to 12 months

• Percentage of Participants in the Non-randomized, Pilot, Cohort Who Completed Clinic Visits

  The percentage of participants in the pilot, non-randomized cohort who completed clinic visits for Supportive Therapy in Androgen Deprivation (STAND) will be reported to assess feasibility.

  Up to 12 months

Secondary Outcomes (19)

• Absolute Change in Blood Pressure (Randomized Cohort)

  Up to 12 months

• Absolute Change in Body Weight (Randomized Cohort)

  Up to 12 months

• Absolute Change in Percentage of Body Fat (Randomized Cohort)

  Up to 12 months

• Absolute Change in Waist Circumference (Randomized Cohort)

  Up to 12 months

• Absolute Change in Hemoglobin A1c (Randomized Cohort)

  Up to 12 months

Study Arms (2)

Arm I (standard of care)

ACTIVE COMPARATOR

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Drug: Goserelin Acetate; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Other: Quality-of-Life Assessment; Drug: Triptorelin Pamoate

Arm II (STAND clinic)

EXPERIMENTAL

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral: Behavioral Dietary Intervention; Other: Counseling; Other: Educational Intervention; Behavioral: Exercise Intervention; Drug: Goserelin Acetate; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Other: Quality-of-Life Assessment; Drug: Triptorelin Pamoate

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Receive individualized nutrition counseling

Arm II (STAND clinic)

Counseling OTHER

Receive individualized symptom management service counseling

Also known as: Counseling Intervention

Arm II (STAND clinic)

Educational Intervention OTHER

Review educational modules

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (STAND clinic)

Exercise Intervention BEHAVIORAL

Receive individualized exercise counseling

Arm II (STAND clinic)

Goserelin Acetate DRUG

Given SC

Also known as: ZDX, Zoladex

Arm I (standard of care); Arm II (STAND clinic)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (standard of care); Arm II (STAND clinic)

Leuprolide Acetate DRUG

Given SC or IM

Also known as: A-43818, Abbott 43818, Abbott-43818, Carcinil, Depo-Eligard, Eligard, Enanton, Enantone, Enantone-Gyn, Ginecrin, LEUP, Leuplin, Leuprorelin Acetate, Lucrin, Lucrin Depot, Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-Ped, Procren, Procrin, Prostap, TAP-144, Trenantone, Uno-Enantone, Viadur

Arm I (standard of care); Arm II (STAND clinic)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (standard of care); Arm II (STAND clinic)

Triptorelin Pamoate DRUG

Given IM

Also known as: Diphereline, Pamorelin, Trelstar

Arm I (standard of care); Arm II (STAND clinic)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic confirmation of adenocarcinoma of the prostate
• Receiving or planning to receive androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
• Expected duration of ADT at least 12 months from date of study consent
• Concurrent antiandrogen therapy allowed but not required
• First dose of LHRH agonist or antagonist no more than 6 months prior to date of study content
• Prior/concurrent radiation allowed
• Other investigational agents in addition to LHRH agonist/antagonist are allowed (e.g. novel anti-androgens, androgen synthesis inhibitors)
• Prior androgen deprivation therapy allowed, provided there is documented evidence of testosterone recovery to \> 150 ng/dL and greater than 12 months duration between last ?effective? date of ADT and date of study consent
• Randomized cohort only:
• No prior chemotherapy within 12 months of start date of study
• No planned chemotherapy at least 12 months from study entry
• Non-randomized pilot cohort:
• Concurrent chemotherapy (initiated within 3 months of study entry) or planned chemotherapy within 3 months of study entry
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 ? 2
• Ability to sign written informed consent

You may not qualify if:

• Physically unable or unwilling to participate in recommended exercise programs or travel to UCSF on a monthly basis
• Presence of permanent pacemaker or implantable medical device
• Artificial joint prostheses and venous filters are allowed

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

Counseling; Early Intervention, Educational; Educational Status; Methods; Goserelin; Leuprolide; luprolide acetate gel depot; Triptorelin Pamoate

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Absolute change calculated for outcomes and and non-parametric statistical tests performed due to small sample size from early study termination. Non-randomized pilot cohort to assess feasibility was not included in group comparisons.

Results Point of Contact

• Title: Li Zhang, PhD
• Organization: University of California, San Francisco

Li.Zhang@ucsf.edu

(415) 476-5339

Study Officials

• Rahul Aggarwal, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: June 20, 2014
• Study Start: June 16, 2014
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: July 23, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)