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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

Overview

Status
Completed
Phase
Phase 2
Enrollment
28 participants (actual)
Sponsor
VA Office of Research and Development · Fed
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Jul 2018
Primary completion
31 Mar 2024
Completion
31 Mar 2024
First posted
29 Sept 2017
Last update posted
1 Aug 2025
Conditions
Newly Diagnosed Oligometastatic Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 2

    Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

    NCT03298087

    1 Jul 2018 to 31 Mar 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Interventions

  • radical prostatectomyProcedure
  • stereotactic body radiotherapyRadiation
  • LeuprolideDrug
  • apalutamideDrug
  • abirateroneDrug

Arms1

  • Experimental

    Experimental Arm

    Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)

    Time frame · 6 months after recovery of testosterone

    Registry description

    PSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.

Secondary outcomes(6)
  1. Time to Biochemical Progression

    Time frame · up to 5 years

    Registry description

    biochemical, radiographic, or clinical

  2. Time to Radiographic Progression

    Time frame · up to 5 years

    Registry description

    per PCWG3 criteria

  3. Time to Initiation of Additional Antineoplastic Therapy

    Time frame · up to 5 years

    Registry description

    antineoplastic therapy includes any systemic or focal anti-prostate cancer therapy

  4. Prostate Cancer Specific Survival

    Time frame · up to 5 years

    Registry description

    Prostate cancer specific survival

  5. Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire

    Time frame · Every 3 months up to a total of 21 months

    Registry description

    This uses the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. It assesses patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Items are rated on a 0 to 4 Likert type scale and combined to produce sub-scores that are summed into a total FACT-P score, the higher the score, the better the quality of life. Range from 0-150 . Data was aggregated per patient and over time. Data represented here are the mean scores and 95% confidence intervals of the participants who filled out the questionnaire (15/24 completed through 18 months, 12/24 completed through 21 months).

  6. Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria

    Time frame · up to 5 years

    Registry description

    CTCAE v4 criteria are a set of criteria for the standardized classification of adverse effects cancer therapy. The CTCAE system is a product of the US National Cancer Institute. The criteria are assessed by physician. The grades range from 0 to 5 (higher is worse). Data will be aggregated per patient and over time and classified by organ system (e.g., genitourinary, gastrointestinal, etc).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 6 months after recovery of testosterone

Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)

GroupValue (Participants)
Experimental Arm20
Secondary and other outcome results(6)
Secondary outcomeMedian· up to 5 years

Time to Biochemical Progression

GroupValue (months)
Experimental ArmNA
Secondary outcomeMedian· up to 5 years

Time to Radiographic Progression

GroupValue (months)
Experimental ArmNA
Secondary outcomeMedian· up to 5 years

Time to Initiation of Additional Antineoplastic Therapy

GroupValue (months)
Experimental ArmNA
Secondary outcomeNumber· up to 5 years

Prostate Cancer Specific Survival

GroupValue (percentage of participants)
Experimental Arm100
Secondary outcomeMean· Every 3 months up to a total of 21 months

Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Scale - Patient Questionnaire

GroupValue (Score on a Scale)
Experimental Arm118
Secondary outcomeCount of participants· up to 5 years

Number of Participants With Treatment-related Adverse Events as Assessed by Physician Using CTCAE v4.0 Criteria

GroupValue (Participants)
Experimental Arm19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Experimental ArmRadical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy. radical prostatectomy: surgical removal of the prostate stereotactic body radiotherapy: Highly targeted radiation Leuprolide: Lowers serum testosterone apalutamide: antiandrogen abiraterone: Inhibits androgen synthesis0 / 281 / 2821 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedParikh NR, Huiza C, Patel JS, Tsai S, Kalpage N, Thein M, Pitcher S, Lee SP, Inouye WS, Jordan ML, Sanati H, Jafari L, Bennett CJ, Gin GE, Kishan AU, Reiter RE, Lewis M, Sadeghi A, Aronson WJ, Garraway IP, Rettig MB, Nickols NG. Systemic and tumor-directed therapy for oligometastatic prostate cancer: study protocol for a phase II trial for veterans with de novo oligometastatic disease. BMC Cancer. 2019 Apr 1;19(1):291. doi: 10.1186/s12885-019-5496-5. PMID 30935383

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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) 1. At least one metastasis must be M1a-b 2. Visceral metastases are not allowed 3. Patients may have any number of pelvic nodal metastases (but largest must be \<2 cm) 4. Metastases must be amenable to treatment with SBRT 5. 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). 4. Patient must be fit to undergo radical prostatectomy, SBRT to all visible sites of metastases, ADT, 5. Total testosterone \>200 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am) 6. Adequate performance status (ECOG 0-1) 7. Clinical laboratory values at screening: 1. Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization 2. Platelet count 100,000 x 109/ L independent of transfusion and/or growth factors within 3 months prior to randomization 3. Serum albumin 3.0 g/dL 4. GFR 45 mL/min 5. Serum potassium 3.5 mmol/L 6. 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) 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 ULN 8. 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: 1. 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) 2. 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 9. Current evidence of any of the following: 1. Uncontrolled hypertension 2. Gastrointestinal disorder affecting absorption 3. Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis) 4. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily 5. Any condition that in the opinion of the investigator would preclude participation in this study 6. Concomitant strong CYP3A4 inducers. (If a strong CYP3A4 inducer must be co-administered, abiraterone acetate dose frequency will be adjusted). 7. 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. 8. Baseline severe hepatic impairment (ChildPugh Class B \& C) 10. Presence of visceral metastases (i.e., stage M1c)

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