A Study of Experimental Radiation Therapy With or Without Apalutamide For Stage III-IV Prostate Cancer

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"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, stage iii prostate cancer, stage iv prostate cancer, stage 3 prostate cancer, stage 4 prostate cancer, recurrent prostate cancer
Type: Drug study, Phase 2
Target:
15 Participants
Investigator:
Description
This research study is for patients with prostate cancer who had surgery to remove the prostate. If your PSA level (a measure of prostate cancer) shows that your cancer has returned, this study may be right for you.

People who are not in a study are usually treated with radiation therapy alone. Some patients may also receive hormone suppression drugs. However, these drugs are FDA approved for more advanced prostate cancer or prostate cancer that has spread. Therefore, hormone suppression drugs are usually not given.

For patients who receive the usual approach (radiation therapy alone), about 62 of 100 patients are free of cancer after 5 years.

This study will compare the effects of using the experimental drug apalutamide (study drug). It will be given along with usual radiation therapy. This combination treatment will be compared to using usual radiation therapy alone.

The study drug is a hormone suppression drug. The study drug is experimental and is not FDA-approved to treat prostate cancer. The addition of the study drug to usual radiation could shrink your cancer/prevent it from returning, but could also cause side effects.

This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should reduce the chance of your cancer growing back compared to the usual approach.
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

Inclusion criteria:

  • Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
  • Post-prostatectomy patients with a detectable serum PSA (≥ 0.1, but ≤ 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:
  • Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)
  • ISUP grade group:
  • Grade Group 1: Gleason score ≤ 6,
  • Grade Group 2: Gleason score 3 + 4 = 7,
  • Grade Group 3: Gleason score 4 + 3 = 7,
  • Grade Group 4: Gleason score 8,
  • Grade Group 5: Gleason scores 9 and 10
  • = T3a disease

  • Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
  • pN0 or pNx
  • History/physical examination within 90 days prior to Step 1 registration
  • Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
  • Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
  • Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for ≤ 90 days duration
  • For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date
  • Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility
  • Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
  • Platelet count ≥ 100,000 x 10^9/uL independent of transfusion and/or growth factors within 90 days prior to step 1 registration
  • Serum albumin ≥ 3.0 g/dL within 90 days prior to Step 1 registration
  • Glomerular filtration rate (GFR) ≥ 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within 90 days prior to Step 1 registration
  • Testosterone > 50 ng/dL within 90 days prior to Step 1 registration
  • Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration.
  • The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
  • The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion criteria:

  • Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
  • Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)
  • History of documented inflammatory bowel disease
  • Transmural myocardial infarction within the last 4 months prior to Step 1 registration.
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
  • History of any condition that in the opinion of the investigator, would preclude participation in this study
  • Current evidence of any of the following:
  • Known gastrointestinal disorder affecting absorption of oral medications
  • Active uncontrolled infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
  • Uncontrolled hypertension
  • Any current condition that in the opinion of the investigator, would preclude participation in this study
  • Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed
  • HIV positive with CD4 count < 200 cells/microliter within 30 days prior to registration
  • HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. (Note: HIV testing is not required for eligibility for this protocol as it is self-reported.)
  • For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation
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
You will receive radiation for 7 - 8 weeks. The study drug/placebo will be taken when radiation starts daily for 6 months. After you finish treatment, your doctor will continue to watch you for side effects and follow your condition: - every 3 months for 2 years - then every 6 months for 3 years - then yearly via office visits.
Recruitment period
From Aug. 3, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • PSA Progression
  • Stage III Prostate Adenocarcinoma
  • Stage IV Prostate Adenocarcinoma

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


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