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Protocol Details

Phase 1/2a, Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Prl-02 Depot;
Abiraterone Decanoate;
Castration-Sensitive Prostate Cancer;
Castration-Resistant Prostate Cancer;

Recruitment Keyword(s)



Prostate Cancer

Investigational Drug(s)

PRL-02 Depot

Investigational Device(s)



Drug: PRL-02 Depot
Drug: Prednisone
Drug: Dexamethasone

Supporting Site

National Cancer Institute


Prostate cancer is the most common cancer in men in the United States. A drug called abiraterone is approved in tablet form to treat this disease. PRL-02 Depot contains another form of this drug that can be injected into a muscle. These injections are being developed so people can get the effects of the drug without having to take tablets every day.


To identify the best dosage of PRL-02 Depot for future studies. Researchers will also look at the safety of PRL-02 and how it works against prostate cancer.


Men aged 18 years and older with advanced prostate cancer.


Participants will be screened for eligibility. They will have a physical exam and provide medical history. They will provide blood and urine samples. They will have tests of heart and lung function. They will have CT scans.

Participants will visit the study site up to 24 times in 13 months, including 5 visits in the first 7 days of the study. Some tests may be repeated at each visit.

Participants will receive PRL-02 as an injection into a muscle near the top of the hip. They may receive up to 4 doses of PRL-02, spaced 12 weeks apart.

Participants will take daily prednisone tablets. Prednisone is a steroid drug that can lower PSA (prostate specific antigen) and reduce pain.

On the final visit participants will have an ACTH (a type of hormone) test. This test will include blood draws just before and 60 minutes after participants receive a hormone injection.

Participants will receive a follow-up phone call 30 days after their final visit.

Sponsoring Institution: Propella Therapeutics, Inc.

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Eligibility criteria applies equally to both Phase 1 and Phase 2a unless otherwise noted.


The patients must meet all of the following criteria:

1. Written informed consent obtained prior to any study-related procedure being performed.

2. Male patients at least 18 years of age or older at time of consent.

3. Histological evidence of adenocarcinoma of the prostate.

4. Patients must have one of the following documented conditions:


-CSPC with biochemical relapse (using the PCWG3 definition of PSA progression) of prostate cancer

-CSPC with oligometastatic prostate cancer (e.g., positron emission tomography positive)


Patients Screened Under Protocol Amendment 4 patients with one or more of the following:

-CTC count of >=5 cells/7.5 mL blood at screening confirmed by the central laboratory

-Measurable disease according to RECIST v1.1 and a target lesion >= 1 cm in size at screening (Exception patients with CSPC and biochemical recurrence)

-PSA value >=2 microliter/L (2 ng/mL) at screening

-Expansion Groups D and E: mCRPC and prior exposure to either abiraterone or enzalutamide

5. Undergone orchiectomy or receiving concurrent GnRH agonist or antagonist therapy for at least 1 month prior to the Screening Visit.

6. A serum T level <50 ng/dL but >=2 ng/dL at screening

7. Adequate muscle mass for an i.m. injection

8. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

9. Adequate bone marrow reserve defined as:

-absolute neutrophil count (ANC) >=1,500/microliter

-platelet (PLT) >=100,000/microliter

-hemoglobin (HGB) >=9 gm/dL

10. Adequate renal function defined as a serum creatinine <=1.5 x the upper limit of normal (ULN) for the reference laboratory or a calculated creatinine clearance >=50 mL/min as determined by a validated algorithm for calculating creatinine clearance.

11. Adequate hepatic function, defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 x the ULN and total bilirubin <=1.5 x the ULN. Exception for elevated bilirubin secondary to Gilbert s disease. Confirmation of Gilbert s diagnosis requires: elevated unconjugated (indirect) bilirubin values; normal complete blood count in previous 12 months, blood smear, and reticulocyte count; normal aminotransferases and alkaline phosphatase in previous 12 months.

12. Serum albumin >=3 gm/dL and serum potassium >=3.5 mEq/L.

13. Patients who are non-sterile and who are heterosexually active with a female partner of childbearing potential must be willing to use a highly effective means of contraception, such as a male condom plus spermicide, from the time of screening, throughout the total duration of the drug treatment, and until 12 weeks after the final dose of study drug.

14. Phase 1 Expansion Groups D and E: Patients must have received prior abiraterone or enzalutamide respectively with documented evidence of progression with one or more of the following:

-- PSA progression defined per PCWG3 criteria as >= 2 occurrences of rising PSA with a minimum of 1 week and a PSA concentration of >= 1ng/ml if confirmed PSA rise is the only measure of progression OR worsening measurable disease on computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1 criteria or at least one new documented lesion on a bone scan.

15. Patients Screened Under Protocol Amendment 4: Evidence of radiographic progression of metastatic disease at study entry, as assessed by the investigator, defined as measurable disease on CT/MRI per RECIST v1.1 or at least one documented bone lesion on a bone scan. Patients whose disease is limited to regional pelvic lymph nodes or local recurrence (e.g. bladder, rectum) are not eligible. Exception: patients with CSPC and biochemical occurrence.


The patients must not meet any of the following criteria:

1. Patients with mCRPC more than minimally symptomatic or with a reported pain score on an 11-point (0-10) numeric rating scale of >3 over the previous 7 days

2. Known active central nervous system (CNS) metastases. Patients with CNS metastases that have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable are eligible.

3. Impending bone fracture due to bone metastases

4. Has a known additional malignancy beyond prostate cancer that required active treatment with the exception of any of the following:

-Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type

-Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for >=2 years

-Any other cancer from which the patient has been disease-free for >=5 years

The Medical Monitor should be contacted for any questions regarding this exclusion criterion.

5. Clinically significant cardiac disease, defined as any of the following:

-Clinically significant cardiac arrhythmias including bradyarrhythmia and/or patients who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Patients with controlled atrial fibrillation are not excluded.

-Congenital long QT syndrome

-QT interval corrected by Fredericia s formula (QTcF) >=450 msec at screening (based on average of triplicate electrocardiograms [ECGs] at baseline). If the QT interval corrected for heart rate intervals (QTc) is prolonged in a patient with a pacemaker or bundle branch block, the patient may be enrolled in the study if confirmed by the Medical Monitor.

-History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association Class II (Appendix 15.2) or left ventricular ejection fraction measurement of <50% at baseline. Patients must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months [NYHA Classification 2014].

-Uncontrolled hypertension, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg which has been confirmed by 2 successive measurements despite optimal medical management

-Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring >1 month before the start of study medication)

6. Participated in an investigational drug study within 5 half-lives of the investigational drug or within 4 weeks of the Screening Visit, whichever is shorter

7. Any unresolved National Cancer Institute (NCI) CTCAE criteria v5.0 Grade >2 toxicity from previous anticancer therapy at the Screening Visit. Patients receiving ongoing replacement hormone therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.

8. Has not recovered from recent major surgery or trauma

9. Received a blood transfusion within 2 weeks of the Screening Visit

10. History of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome)

11. Prior treatment with abiraterone, orteronel, or current treatment with systemic ketoconazole or any other CYP17 inhibitor. Exception: patients in Phase 1 Expansion Group D may have received prior abiraterone.

12. Current treatment with enzalutamide, flutamide, nilutamide, bicalutamide, or any other AR blocking agents. Patients who have received anti-androgens or AR blocking agents must have discontinued bicalutamide >=6 weeks and other antiandrogens >=4 weeks prior to the Screening Visit.

13. Prior treatment with estrogens within the previous 3 months

14. Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal, or intra-articular glucocorticoids is permitted.

15. Prior use of any herbal products that could decrease PSA levels (e.g., saw palmetto) within 30 days of the Screening Visit. Patients must agree not to use such herbal products during study participation.

16. Use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 microgram [NIH-ODS 2021]. Note: Patients who switch from a high dose to a dose of 30 microgram/day or less are eligible for study entry.

17. Required concomitant use of strong inducers of CYP3A4

18. Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components

19. Has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive), hepatitis B (hepatitis B virus surface antigen [HBsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid)

20. Hemoglobin A1c (HbA1c) >10% in patients previously diagnosed with diabetes mellitus. HbA1c >8% in patients whose diabetes mellitus is previously undiagnosed. (Excluded patients may be rescreened after referral and evidence of improved control of their condition).

21. Uncontrolled infection with human immunodeficiency virus human immunodeficiency virus (HIV)+. Exception: patients with well-controlled HIV (e.g., CD4 >350/mm3 and undetectable viral load) are eligible.

22. Body mass index >40 kg/m2

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Not Provided

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Principal Investigator

Referral Contact

For more information:

William D. Figg, Pharm.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 5A01
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6179

Deneise Francis, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N222
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3974

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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