SWOG clinical trial number
S1802

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Open
Phase
Accrual
2%
Abbreviated Title
PhIII Rando SST v. SST+Surgery or Radiation for Met Prostate Cancer
Status Notes
Activated 9/17/18.
Activated
09/17/2018
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Research committees

Genitourinary Cancer
Other
Symptom Control and Quality of Life

Eligibility Criteria Expand/Collapse

STEP 1 REGISTRATION
*Pts must have a histologically or cytologically proven adenocarcinoma of the prostate. Pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible.
*Pts must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed. Any prior therapy for benign conditions are acceptable.
*Pts must have evidence of metastatic disease on technetium bone scan and CT or MRI within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by PET scan or solitary metastases by conventional imaging must be confirmed histologically or cytologically.
*Pts with known brain metastases are not eligible.
*Pts must have received no more than 28 weeks of SST.
*Pts must not have progressed while on SST.
*Pts with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
*Pts must be ≥ 18 years of age.
*Pts must have a complete physical examination and medical history within 28 days prior to registration.
*Pts must have a PSA documented prior to initiation of SST and within 28 days prior to registration.
*Pts must have a testosterone lab documented within 28 days prior to randomization.
*No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
*Pts must be offered the opportunity to participate in translational medicine studies and specimen banking.
*Pts who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.

STEP 2 RANDOMIZATION
*Pts must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration within 28 days prior to randomization.
*Pts must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
*Pts must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration.
*Pts must not be planning to receive docetaxel after randomization.
*Any toxicities from SST must have resolved to ≤ Grade 1 (CTCAE Version 5.0) prior to randomization.
*Pts may have received elective metastasis directed therapy to oligometastatic sites (≤4 sites). All treatment must be completed prior to randomization.
*Pts must have a PSA performed within 28 days prior to randomization.
*Pts must have a testosterone < 50 ng/dL within 28 days prior to randomization.
*Patients must have a Zubrod performance status of 0 – 1 within 28 days prior to randomization.

Publication Information Expand/Collapse

2018

Key Design and Analysis Principles for Quality of Life and Patient Reported Outcomes in Clinical Trials

J Unger;R Vaidya;J Gore Urologic Oncology Mar 20 [Epub ahead of print]

PMid: PMID29572075 | PMC number: NIHMSID946008

Reports & Approvals

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