Clinical trial · Interventional
A Study of Definitive Therapy to Treat Prostate Cancer
A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer
- 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)
To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Prostatectomy | Procedure | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemohormonal and definitive therapy
- description
- (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
- interventionNames
- Drug: Leuprolide Acetate
- Drug: Bicalutamide
- Drug: Docetaxel
- Procedure: Prostatectomy
- Radiation: Radiation
Primary outcomes (1)
- measure
- Efficacy as Assessed by 2-year PSA Progression-free Survival Rate
- timeFrame
- 2 years
- description
- To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA\<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide written informed consent. * Age ≥ 18 years * Eastern cooperative group (ECOG) performance status ≤2 * Documented histologically confirmed adenocarcinoma of the prostate * Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full year of androgen deprivation. * Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or positron emission tomography scan) * Able to swallow the study drugs whole as tablets Exclusion Criteria: * Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy) * Prior therapy to a metastatic site. * Prior or ongoing systemic therapy for prostate cancer including, but not limited to: 1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix) 2. Cytochrome (CYP) -17 inhibitors (e.g. ketoconazole) 3. Antiandrogens (e.g. bicalutamide, nilutamide) 4. Second generation antiandrogens (e.g. enzalutamide, abiraterone) 5. Immunotherapy (e.g. sipuleucel-T, ipilimumab) 6. Chemotherapy (e.g. docetaxel, cabazitaxel) \*Note: may be enrolled if hormone therapy was recently initiated (\<90 days duration). In the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment. * Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. * Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. * Abnormal bone marrow function \[absolute neutrophil count (ANC)\<1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL\] * Abnormal liver function (bilirubin \>upper limit of normal; aspartate aminotransferase , alanine aminotransferase \> 2.5 x upper limit of normal) * Creatinine clearance of ≥ 30 mL/min. Creatinine clearance should be calculated suing the Cockcroft-Gault formula. * Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months. * Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.
References
Publications (0)
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