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Reolysin Combined With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Metastatic Castration Resistant Prostate Cancer

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. Read our disclaimer for details. Identifier: NCT01619813
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : April 7, 2020
Oncolytics Biotech
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Brief Summary:
The purpose of this study is to find out if giving Reolysin in combination with docetaxel and prednisone can offer better results than standard therapy with docetaxel and prednisone.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel, Reolysin and Prednisone Drug: Docetaxel and Prednisone Phase 2

Detailed Description:
Researchers doing this study also want to evaluate the side effects of Reolysin when given together with docetaxel and prednisone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer
Actual Study Start Date : July 11, 2012
Actual Primary Completion Date : April 26, 2016
Actual Study Completion Date : May 20, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Docetaxel, Reolysin and Prednisone Drug: Docetaxel, Reolysin and Prednisone
Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly beginning on day 1, cycle 1. Reolysin will be delivered as a 1-hour infusion days 1-5. On day 1 of each cycle, when both agents are given, the docetaxel will be given first. Prednisone 5 mg BID will be given beginning day 1. Each cycle is 3 weeks in length.

Active Comparator: Docetaxel and Prednisone Drug: Docetaxel and Prednisone
Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly. Prednisone 5mg BID will be given beginning Day 1. Each cycle is 3 weeks in length.

Primary Outcome Measures :
  1. Disease Progression [ Time Frame: 12 weeks ]
    Efficacy will be based on the lack of disease progression measured at 12 weeks.

Secondary Outcome Measures :
  1. Effect of Docetaxel and Reolysin on circulating tumour cells [ Time Frame: 12 weeks ]
    Effect of docetaxel and Reolysin on the circulating tumour cell (CTC) favourable status (< 5 CTC per 7.5mL). Effect will be measured after 6 and 12 weeks of treatment.

  2. PSA change rate [ Time Frame: 24 months ]
  3. Objective Response [ Time Frame: 24 months ]
    Objective response rate (in patients with measurable disease at baseline)

  4. Overall Survival [ Time Frame: 24 months ]
  5. Determine patient tolerability and toxicity of Reolysin and Docetaxel in combination [ Time Frame: 24 months ]
    Determine the effect of Reolysin and Docetaxel in combination in patients.

  6. Prognostic/Predictive molecular response [ Time Frame: 24 months ]
    Explore potential molecular factors which might be prognostic/predictive of response (tumour, CTCs, serial blood samples).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Patients must have a histological diagnosis of adenocarcinoma of the prostate.
  • All patients must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour) available for translational studies.
  • Presence of clinically and/or radiologically documented disease (measurable or non-measurable). All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative). Patients with elevated PSA only are not eligible.
  • Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present.
  • Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration.

Progression is defined as one or both of the following:

PSA Progression:

A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥2 ng/ml and must be performed no longer than 7 days prior to trial randomization. Patients who have had prolonged responses to combined androgen blockade should be evaluated for a withdrawal response prior to confirming eligibility OR

Radiological Progression:

defined as the development of new metastatic lesions or progression in target disease (RECIST 1.1) with a stable or rising PSA.

  • The PSA must be ≥ 5 ng/ml at the time of study entry.
  • ECOG performance of 0, 1 or 2.
  • Age ≥ 18 years of age.
  • Patients must have a life expectancy of ≥ 12 weeks.
  • Previous Therapy


Previous major surgery is permitted provided that it has been at least 14 days prior to patient randomization and that wound healing has occurred.


Patients may NOT have received any prior cytotoxic chemotherapy for recurrent/metastatic castration resistant prostate cancer. Prior docetaxel treatment is not permitted unless it was provided on an adjuvant therapy protocol more than 12 months prior to study enrollment.

Hormonal Therapy:

Prior hormone therapy is required. Patients must be castrate resistant and have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate level of testosterone must be present. Prior therapy with CYP17 inhibitors (e.g. abiraterone, ketoconazole) or novel anti-androgens (e.g. MDV3100) is permitted.


Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG. Prior strontium is not permitted.

  • Laboratory Requirements (must be done within 7 days prior to randomization)


Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L


Serum creatinine ≤ 1.5 x ULN Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to conditions such as Gilbert's disease) ALT and AST ≤ 1.5 x ULN Proteinuria <2g/24hrs (screen using spot testing; if ≥ grade 2 repeat with mid-stream urine - if still ≥ grade 2 then urine collection for 24 hours to confirm <2g/24hrs)

  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.

Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.

  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.

Exclusion Criteria:

  • Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for ≥ 3 years.(Please call NCIC CTG if any questions about the interpretation of this criterion).
  • Patients who are on immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
  • Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
  • Patients with history of central nervous system metastases or untreated spinal cord compression.
  • Patients who have had prior treatment with docetaxel for advanced/metastatic disease.
  • Men who are not sterile unless they use an adequate method of birth control.

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): NCT01619813

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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Canadian Cancer Trials Group
Oncolytics Biotech
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Study Chair: Bernhard Eigl BCCA Vancouver
Publications of Results:
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Responsible Party: Canadian Cancer Trials Group Identifier: NCT01619813    
Other Study ID Numbers: I209
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal