Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01548807
Recruitment Status : Recruiting
First Posted : March 8, 2012
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This is a Phase 1 dose escalation study of an investigational agent, everolimus, given in combination with standard radiation therapy, in prostate cancers with a rising PSA following a prostatectomy. A maximum of 33 people will be enrolled on this study at the University of Pennsylvania. The primary objective of this study is to determine the acute and chronic toxicities and maximum tolerated dose of everolimus with concurrent radiation.

Condition or disease Intervention/treatment Phase
Prostate Cancer Patients With Detectable PSA Following Prostatectomy Drug: Everolimus (RAD001) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Primary Purpose: Treatment
Official Title: Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy
Study Start Date : September 2010
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Number of Participannts with Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • - Patient must have a history of prostatectomy (Open Radical or Robotic Assisted) with histopathologic documentation of adenocarcinoma of the prostate
  • Patient must have biochemical evidence of PSA including one of the following: a). biochemical recurrence (defined as nadir + 2 rises measured at least 2 weeks apart) and b). PSA doubling time of less than or equal to 6 months; OR c). persistently elevated PSA(PSA post prostatectomy of 0.2 ng/mL if standard assay or greater than 0.05 if ultrasensitive PSA assay)
  • Patient must be a candidate for salvage radiotherapy to the prostate bed
  • Age greater or equal to 18 years
  • ECOG performance status less than or equal to 1
  • Adequate bone marrow function
  • Adequate liver and renal function Adequate renal function: serum creatinine 1.5 x ULN
  • Signed informed consent
  • Patient must have archival prostate tumor block available for analysis of correlatives

Exclusion Criteria:

  • - Indication for lymph node radiation (i.e. evidence of LB node metastases)
  • Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
  • Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
  • Patients should not receive immunization with attenuated liver vaccines within one week of study entry or during study period. Close contact with those who have received attenuated liver vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines.
  • Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

    1. . Symptomatic congestive heart failure of New York heart Association Class III or IV
    2. . unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
    3. . severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
    4. . uncontrolled diabetes
    5. . active (acute or chronic) or uncontrolled severe infections
    6. . liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.

  • A known history of HIV seropositivity as everolimus has immunosuppressant properties
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis
  • Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
  • Patients with a known hypersensitivity to everolimus (RAD001) or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Male patient whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01548807

Contact: Naomi Haas, MD 855-216-0098

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19004
Contact: Naomi Haas, MD    855-216-0098   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Principal Investigator: Naomi Haas, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01548807     History of Changes
Other Study ID Numbers: UPCC 06810
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents