Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer
Condition: Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Behavioral Dietary Intervention; Counseling; Educational Intervention; Exercise Intervention; Goserelin Acetate; Laboratory Biomarker Analysis; Leuprolide Acetate; Quality-of-Life Assessment; Triptorelin Pamoate
Intervention description: Receive individualized nutrition counseling; Receive individualized symptom management service counseling; Review educational modules; Receive individualized exercise counseling; Given SC; Correlative studies; Given SC or IM; Ancillary studies; Given IM
Intervention MeSH terms: Leuprolide; Goserelin; Triptorelin Pamoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Healthy volunteers: No

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.
    

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