Experimental Standard Systemic Therapy With or Without Surgery or Radiation For Metastatic Prostate Cancer

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Male
Healthy Volunteers: No
Keywords: prostate cancer, metastatic prostate cancer
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
This study is being done to test if we can lower the chance of your prostate cancer growing or spreading. We will test adding either prostate removal surgery or radiation therapy to standard treatment.

We hope to find out if this will be better or worse than the usual approach for your prostate cancer.

This study will compare the effects of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST). SST is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT). It is given with or without the use of chemotherapy. ADT is an antihormone therapy whose main use is in treating prostate cancer. The combination of SST and surgery or radiation therapy is considered experimental.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Disease-Related Criteria

  1. 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).

  2. Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, 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).

  3. Patients 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 only (NaF, PSMA, FACBC, C11) but not conventional imaging (Tc99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.

  4. 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.

Prior/Concurrent Therapy Criteria

  1. Patients must have received no more than 28 weeks of SST. SST is defined as current NCCN guidelines for metastatic prostate cancer.

  2. Patients must not have progressed while on SST.

  3. Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.

Clinical/Laboratory Criteria

  1. Patients must be ≥ 18 years of age.

  2. Patients must have a complete physical examination and medical history within 28 days prior to registration.

  3. Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.

  4. Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.

  5. 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.

Specimen Submission Criteria

  1. Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.

Quality of Life Criteria

  1. Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.

Regulatory Criteria

  1. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

  2. As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

STEP 2 RANDOMIZATION

Disease-Related Criteria

  1. Patients 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 (as defined by physician discretion) within 28 days prior to randomization.

  2. Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.

Prior/Concurrent Therapy Criteria

  1. Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.

  2. Patients must not be planning to receive docetaxel after randomization.

  3. Any toxicities from SST must have resolved to ≤ Grade 1 (CTCAE Version 5.0) prior to randomization.

  4. Patients may have received elective metastasis directed therapy to oligometastatic sites (≤4 sites). All treatment must be completed prior to randomization.

Clinical/Laboratory Criteria

  1. Patients must have a PSA performed within 28 days prior to randomization.

  2. Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.

  3. Patients must have a Zubrod performance status of 0 – 1 within 28 days prior to randomization.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
If you decide to take part in this study, you will receive the study treatment for 22-28 weeks. After you finish your study treatment, the study team will follow-up with you for up to 8 years. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits every three months for the first three years, then every six months until your prostate cancer becomes worse. If it worsens, you will have clinic visits every six months for the first three years and then once a year after that.
Recruitment period
From Oct. 19, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
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

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview