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Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

ConditionsCastration Levels of TestosteroneMetastatic Prostatic AdenocarcinomaStage IV Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorSWOG Cancer Research Network

About this trial

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).

STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).

STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride [NaF], prostate-specific membrane antigen [PSMA], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.

STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abiraterone

    Drug

    Given PO

  • Bicalutamide

    Drug

    Given PO

  • Degarelix

    Drug

    Given via injection

  • Docetaxel

    Drug

    intravenous

  • Flutamide

    Drug

    Given PO

  • Goserelin Acetate

    Drug

    Given SC

  • Histrelin Acetate

    Drug

    Receive SC

  • Leuprolide Acetate

    Drug

    Receive SC or IM

  • Nilutamide

    Drug

    Given PO

  • Orchiectomy

    Procedure/Surgery

    Undergo bilateral orchiectomy

  • Prednisone

    Drug

    Given PO

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Radiation Therapy

    Radiation

    Standard radiation

  • Radical Prostatectomy

    Procedure/Surgery

    Standard surgery

  • Triptorelin

    Drug

    injection

Treatment groups

1,273 Participants
are divided into 3 treatment groups
Group A: Arm I (SST)Active comparator 11 interventions
Group B: Arm II (SST, prostatectomy or radiation therapy)Experimental treatment 13 interventions
Group C: Step 1 (pre-randomization)Active comparator 13 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time frame
From date of randomization to date of death due to any cause, assessed up to 8 years

Secondary outcomes

1

Media OS

Will compare OS in metastatic prostate cancer patients who received standard systemic therapy (SST) plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.

Time frame
From date of randomization to date of death due to any cause, assessed up to 8 years
2

Rate of symptomatic local progression

Defined as any of the following events post-randomization: Common Terminology Criteria for Adverse Events version 5 grade \>= 2 hematuria, urinary retention, urinary tract obstruction, urinary tract pain, pelvic pain, renal and urinary disorders-other. Will be compared between the treatment arms. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

Time frame
Up to 8 years
3

Progression-free survival (PFS)

Will be compared between for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites. A proportional hazards model will be fit to each of these endpoints where the time interval starts at date of randomization to (i) time of first symptomatic local progression or ii) progression or death due to any cause, where those without the event are censored at their last contact date. Stratification factors will be adjusted for as covariates.

Time frame
From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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