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

Conditions

• Castration Levels of Testosterone
• Metastatic Prostatic Adenocarcinoma
• Stage IV Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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
  Undergo bilateral orchiectomy
• Prednisone — DRUG
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Radiation Therapy — RADIATION
  Standard radiation
• Radical Prostatectomy — PROCEDURE
  Standard surgery
• Triptorelin — DRUG
  injection

Study Details

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.

Key Dates

Start date

Sep 24, 2018

Status verified

Sep 2025

Primary completion

Apr 1, 2028

Completion

Oct 1, 2031

Study Design

Enrollment

1,273 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (SST)
  Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone.
• Experimental: Arm II (SST, prostatectomy or radiation therapy)
  Participants receive 1 acceptable form of SST as in Induction except for treatment with docetaxel and prednisone. Participants undergo prostatectomy within 8 weeks after randomization or radiation therapy within 4 weeks of randomization.
• Active Comparator: Step 1 (pre-randomization)
  Standard treatment data collection prior to randomization

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years ]

Central Contacts

• Dana Sparks, MAT
  2106148808
  [email protected]

Locations (334)

Find similar trials in Gilbert, AZ

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