Clinical trial · Interventional
Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)
A Prospective, Multi-Institutional, Randomized, Phase II Trial of Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Metastatic (M1) Prostate Cancer (PC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if treatment with standard systemic therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery or radiation therapy is more effective at controlling prostate cancer than standard systemic therapy alone. The safety of this treatment combination will also be studied.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Systemic Therapy (BST) | Other | — | UNRESOLVED |
| Best Systemic Therapy (BST) + Surgery or Radiation Therapy | Other | — | UNRESOLVED |
| Phone Call/Email | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Best Systemic Therapy (BST)
- description
- Group 1 will continue to receive best systemic therapy (BST). Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete. Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.
- interventionNames
- Other: Best Systemic Therapy (BST)
- Behavioral: Questionnaires
- Other: Phone Call/Email
- type
- EXPERIMENTAL
- label
- Best Systemic Therapy (BST) + Surgery or Radiation Therapy
- description
- Group 2 will receive best systemic therapy (BST) in addition to surgery to remove prostate or radiation therapy to the prostate. Treating physician will decide if surgery or radiation therapy is the best choice. Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete. Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients 2. 18 yrs and older 3. Histologically or cytologically proven prostate carcinoma 4. Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI. 5. Androgen dependent disease measured by declining PSA and do not display signs of progression demonstrated by a rising PSA. 6. Treatment initiation with BST no longer than 6 months prior to randomization 7. ECOG PS 0 or 1 8. Life-expectancy based on comorbid conditions \>2 years 9. Ability to understand and willingness to sign informed consent 10. Must be a candidate for surgery and/or radiation therapy Exclusion Criteria: 1. Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely. 2. Known brain metastasis 3. Small cell carcinoma of the prostate 4. Any laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study. For example: AST + ACT \> 2 upper limits of normal value; WBC \< 2.0; Hgb \< 7.0.
References
Publications (0)
Data not yet available