Clinical trial NCT02168062: Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer
Official title: A Multidisciplinary Team-Based Approach to Mitigate the Impact of Androgen Deprivation Therapy in Prostate Cancer: A Randomized Phase 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-20
Enrollment: 57
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. To compare the mean percent change from baseline to 12 months in percentage body fat mass among men with prostate cancer receiving androgen deprivation therapy randomized to participate in the ?STAND? clinic versus (vs.) usual standard of care. (Randomized Cohort) II. To determine the feasibility of completing multi-disciplinary STAND clinic visits within context of concurrent chemohormonal therapy for prostate cancer. (Non-randomized Pilot Cohort)

SECONDARY OBJECTIVES:

I. To compare the mean percent change from baseline to 12 months and patterns of change over time during participation in the STAND clinic vs. usual standard of care with respect to: metabolic impact on diabetes and cardiovascular risk factors, bone health, and quality of life/psychosocial impact.

II. Among men randomized to receive usual standard of care that cross-over to participate in the STAND clinic after month 12 of the study: to measure the mean change from baseline at start of participation in the STAND clinic after 12 months of participation in: metabolic parameters including percentage body fat, fasting insulin/glucose, homeostatic model assessment insulin resistance (HOMA-IR), body weight/body mass index, waist circumference; bone health; quality of life; and patient satisfaction.

III. Among men in the non-randomized pilot cohort: to determine the mean change from baseline to 12 months during STAND clinic participation in the primary and secondary metabolic and quality of life parameters listed above.

TERTIARY OBJECTIVES:

I. To investigate for a relationship between inherited genetic polymorphisms of functional relevance near or within genes encoding proteins with roles in steroid hormone transport and androgen receptor signaling with changes in metabolic parameters among men treated with androgen deprivation therapy.

II. To investigate changes in trabecular bone micro-architecture as measured by high resolution peripheral quantitative computed tomography (QCT) Imaging of radius and tibia during androgen deprivation therapy.

III. To investigate for relationship between 2nd digit to 4th digit length ratio (2D:4D ratio) and quality of life on androgen deprivation therapy.

IV. To investigate for a relationship between 2nd digit to 4th digit length ratio and baseline empathy score as measured by validated questionnaire.

OUTLINE: Patients receiving androgen deprivation therapy are randomized to 1 of 2 arms and patients receiving concurrent chemohormonal therapy are assigned to Arm II.

ARM I (STANDARD OF CARE): Patients receive leuprolide acetate subcutaneously (SC) or intramuscularly (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.

ARM II (STAND CLINIC): 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.

After completion of study treatment, patients are followed up at 2, 4, and 6 months.

Eligibility criteria: Inclusion Criteria:

* 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
* Willing to attend monthly clinic visits at University of California, San Francisco (UCSF)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Absolute Change in Percentage Body Fat Mass as Measured by Bioelectrical Impedance Analyzer (Randomized Cohort)
timeFrame: Up to 12 months
measure: Percentage of Participants in the Non-randomized, Pilot, Cohort Who Completed Clinic Visits
timeFrame: Up to 12 months
Secondary outcomes:
measure: Absolute Change in Blood Pressure (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Body Weight (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Percentage of Body Fat (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Waist Circumference (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Hemoglobin A1c (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Insulin Resistance Score (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Fasting Lipids (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Average Moderate to Vigorous Physical Activity (MVPA) as Measured by an Ambulatory Accelerometer Assessment (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Bone Density T-score (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Serum 25-(OH) Vitamin D (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Patient Health Questionnaire-9 (PHQ-9) Scores (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Attention Function Index (AFI) Scores (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in the 12-item Short Form Survey (SF-12) Assessment Item Scores for Patients in the Randomized Cohort
timeFrame: Up to 12 months
measure: Absolute Change in International Prostate Symptom Score (IPSS) (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Last Question on International Prostate Symptom Score (IPSS) (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Hot Flash Related Daily Interference Scale Score (HFRDIS) (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort)
timeFrame: Up to 12 months
measure: Absolute Change in Lee Fatigue Scale Scores (Randomized Cohort)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rahul Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: