Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer


Condition: Newly Diagnosed Oligometastatic Prostate Cancer

Intervention:

  • Procedure: radical prostatectomy
  • Radiation: stereotactic body radiotherapy
  • Drug: Leuprolide
  • Drug: apalutamide
  • Drug: abiraterone

Purpose: This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate), six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03298087

Sponsor: VA Office of Research and Development

Primary Outcome Measures:

  • Measure: PSA<0.05ng/mL
  • Time Frame: 6 months after recovery of testosterone
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: time to biochemical progression
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Time to radiographic progression
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Time to initiation of additional antineoplastic therapy
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Prostate cancer specific survival
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Patient reported outcomes as assedded by Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire
  • Time Frame: up to 5 years
  • Safety Issue:
  • Measure: Number of participants with treatment-related adverse events as assessed by physician using CTCAE v4.0 criteria
  • Time Frame: up to 5 years
  • Safety Issue:

Estimated Enrollment: 28

Study Start Date: July 1, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Biopsy confirmed diagnosis of prostate adenocarcinoma (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed)
  2. Age 18
  3. Presence of 1-5 visible metastases (by NaF PET-CT or PSMA PET-CT including diagnostic CT of the chest, abdomen, and pelvis)
  4. At least one metastasis must be M1a-b
  5. Visceral metastases are not allowed
  6. Patients may have any number of pelvic nodal metastases (but largest must be <2 cm)
  7. Metastases must be amenable to treatment with SBRT
  8. Biopsy of one metastasis must be attempted, unless unsafe to perform. If biopsy is not diagnostic, or unsafe to perform, then a secondary imaging modality (for example, MRI) must also be consistent with metastatic disease (unless PSMA PET-CT was used as initial staging).
  9. Patient must be fit to undergo radical prostatectomy, SBRT to all visible sites of metastases, ADT,
  10. Total testosterone >200 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am)
  11. Adequate performance status (ECOG 0-1)
  12. Clinical laboratory values at screening:
  13. Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  14. Platelet count 100,000 x 109/ L independent of transfusion and/or growth factors within 3 months prior to randomization
  15. Serum albumin 3.0 g/dL
  16. GFR 45 mL/min
  17. Serum potassium 3.5 mmol/L
  18. Serum total bilirubin 1.5 ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 ULN, measure direct and indirect bilirubin and if direct bilirubin is 1.5 ULN, subject may be eligible)
  19. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 ULN
  20. Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry.

Exclusion Criteria:

  1. Any evidence of spinal cord compression (radiological or clinical)
  2. Prior pelvic malignancy
  3. Prior pelvic radiation
  4. Concurrent malignancy aside from superficial skin cancers or superficial bladder tumors
  5. Inability to undergo prostatectomy, radiotherapy, or ADT
  6. Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)
  7. Inflammatory bowel disease or active collagen vascular disease
  8. History of any of the following:
  9. Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  10. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  11. Current evidence of any of the following:
  12. Uncontrolled hypertension
  13. Gastrointestinal disorder affecting absorption
  14. Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
  15. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
  16. Any condition that in the opinion of the investigator would preclude participation in this study
  17. Concomitant strong CYP3A4 inducers. (If a strong CYP3A4 inducer must be co-administered, abiraterone acetate dose frequency will be adjusted).
  18. Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered.
  19. Baseline severe hepatic impairment (ChildPugh Class B & C)
  20. Presence of visceral metastases (i.e., stage M1c)

Contact:

  • Nicholas G Nickols, MD PhD
  • (310) 478-3711

Locations:

  • VA Long Beach Healthcare System, Long Beach, CA
  • Long Beach California 90822 United States
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • West Los Angeles California 90073 United States

View trial on ClinicalTrials.gov


E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe