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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

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer Patients With Detectable PSA Following Prostatectomy

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Trial Information

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

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

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

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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Number of Participannts with Adverse Events

Safety Issue:


Principal Investigator

Naomi Haas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 06810



Start Date:

September 2010

Completion Date:

September 2015

Related Keywords:

  • Prostate Cancer Patients With Detectable PSA Following Prostatectomy
  • Prostatic Neoplasms
  • Recurrence



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283