AzTrials
AzTrials

Prostate CancerPhase 2NCT01619813

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

A Phase 2 study testing Docetaxel, Reolysin and Prednisone and Docetaxel and Prednisone in people with Prostate Cancer, run by Canadian Cancer Trials Group at 11 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Docetaxel, Reolysin and Prednisone and Docetaxel and Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
11 sitesCanada
Study dates
14 Dec 2012to 20 May 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 32Show fewer
  • 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
  • Surgery:
  • Previous major surgery is permitted provided that it has been at least 14 days prior to patient randomization and that wound healing has occurred.
  • Chemotherapy:
  • 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.
  • Radiation:
  • 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)
  • Hematology:
  • Granulocytes (AGC) ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L
  • Biochemistry:
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • BCCA - Abbotsford Centre

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Read the detailed description

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

Conditions
Prostate Cancer
Being tested
Docetaxel, Reolysin and Prednisone, Docetaxel and Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel, Reolysin and PrednisoneDrug

    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.

  • Docetaxel and PrednisoneDrug

    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.

Study groups in NCT01619813
Study groupRoleWhat they receive
Docetaxel, Reolysin and PrednisoneActive comparatorNot described
Receives: Drug: Docetaxel, Reolysin and Prednisone
Docetaxel and PrednisoneActive comparatorNot described
Receives: Drug: Docetaxel and Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Progression

    Efficacy will be based on the lack of disease progression measured at 12 weeks.

    Measured: 12 weeks

Secondary outcomes (6)

  1. Effect of Docetaxel and Reolysin on circulating tumour cells

    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.

    Measured: 12 weeks

  2. PSA change rate

    Measured: 24 months

  3. Objective Response

    Objective response rate (in patients with measurable disease at baseline)

    Measured: 24 months

  4. Overall Survival

    Measured: 24 months

  5. Determine patient tolerability and toxicity of Reolysin and Docetaxel in combination

    Determine the effect of Reolysin and Docetaxel in combination in patients.

    Measured: 24 months

  6. Prognostic/Predictive molecular response

    Explore potential molecular factors which might be prognostic/predictive of response (tumour, CTCs, serial blood samples).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2012 (estimated)
  2. Study start14 Dec 2012
  3. Primary completion26 Apr 2016
  4. Study completion20 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01619813
Sponsor's protocol ID
I209
Status last verified
Apr 2020
First submitted
12 Jun 2012
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eigl BJ, Chi K, Tu D, Hotte SJ, Winquist E, Booth CM, Canil C, Potvin K, Gregg R, North S, Zulfiqar M, Ellard S, Ruether JD, Le L, Kakumanu AS, Salim M, Allan AL, Feilotter H, Theis A, Seymour L. A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209. Oncotarget. 2018 Jan 17;9(8):8155-8164. doi: 10.18632/oncotarget.24263. eCollection 2018 Jan 30.

    PubMed 29487723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Reolysin and Prednisone and Docetaxel and Prednisone in people with Prostate Cancer, run by Canadian Cancer Trials Group at 11 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Progression (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01619813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in