Clinical trial · Interventional
Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer
A Multidisciplinary Team-Based Approach to Mitigate the Impact of Androgen Deprivation Therapy in Prostate Cancer: A Randomized Phase 2
NCT02168062CI-TRIAL-00046131terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | — | UNRESOLVED |
| Counseling | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Goserelin Acetate | Drug | Goserelin | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (standard of care)
- description
- 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.
- interventionNames
- Drug: Goserelin Acetate
- Other: Laboratory Biomarker Analysis
- Drug: Leuprolide Acetate
- Other: Quality-of-Life Assessment
- Drug: Triptorelin Pamoate
- type
- EXPERIMENTAL
- label
- Arm II (STAND clinic)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.