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GTN Therapy on Biomarkers of Immune Escape in Men With Biochemical Recurrence of Prostate Cancer After Primary Therapy (GTN)

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ClinicalTrials.gov Identifier: NCT01704274
Recruitment Status : Unknown
Verified November 2013 by Dr. D. Robert Siemens, Queen's University.
Recruitment status was:  Recruiting
First Posted : October 11, 2012
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. D. Robert Siemens, Queen's University

Brief Summary:

Prostate cancer is the most commonly diagnosed cancer in men in Canada. Over 30% of men over the age of fifty have histological evidence of prostate cancer on biopsy. Despite the stage migration afforded by early detection with serum prostate specific antigen (PSA) testing and an apparent trend toward improved survival over the past several years, prostate cancer remains a significant cause of morbidity and mortality. Biochemical failure after primary therapy (surgery or radiation) remains a significant health care burden and strategies to delay clinical prostate cancer progression and prolong the interval from treatment failure to systemic therapy would be of significant clinical benefit for those men suffering from a finding of PSA recurrence.

PSA is widely accepted as the most useful prognostic marker of prostate cancer progression, particularly after primary therapy with radical surgery or radiation. 5 Despite improved cancer control rates with definitive management of early stage prostate cancer, a PSA recurrence is unfortunately a common occurrence (25-50%) in most large case series.

Microenvironmental factors have been demonstrated to play a pivotal role in the selection of neoplastic cell subpopulations expressing more malignant phenotypes and contributing to the progression of localized and metastatic disease. Very low levels of O2 (< 10 mmHg) has been well described in many solid tumours (including prostate cancer) and the extent of hypoxia has been demonstrated to represent an independent marker of a poor prognosis for patients with various types of cancers. Tumour hypoxia contributes to numerous adaptive phenotypes including increased invasion and metastasis, as well as evasion of immune cell surveillance increased resistance to radiotherapy and chemotherapy. Although cellular adaptive responses to hypoxia are likely mediated by various mechanisms, our previous preclinical studies suggest that decreased nitric oxide (NO)-dependent signalling plays a significant role in this progression of a malignant phenotype.


Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Low Dose GTN 0.0285 mg/hr Other: High Dose GTN 0.057 mg/hr Other: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-Blind, Randomised, Placebo-Controlled Study of the Effect of Transdermal Nitroglycerin (Glyceryl Trinitrate; GTN) Therapy on Biomarkers of Immune Escape in Men With Biochemical Recurrence of Prostate Cancer After Primary Therapy
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo patch
Other: Placebo
Placebo

Experimental: Low dose GTN 0.0285 mg/hr
Low dose GTN
Other: Low Dose GTN 0.0285 mg/hr
Low Dose GTN

Experimental: High Dose GTN 0.057 mg/hr
High Dose GTN
Other: High Dose GTN 0.057 mg/hr
High Dose GTN




Primary Outcome Measures :
  1. Change in the following biomarkers: inflammatory/immune markers uPAR, PAI-1, ULBP2, B7-H1, MIF, TGF-β; and PSA compared to placebo. [ Time Frame: 12 months ]
    All assessments are as per standard of care. The only additional intervention is a 5 mL peripheral vein phlebotomy at each visit. Patients will be followed at 3, 6, 9 and 12 months after initiation of the trial. Clinic visits will assess side effects of drug and include routine follow-up for prostate cancer management. Serum samples for the above-described makers of immune activity will be obtained at the month 3, 6, 9 and 12 visit.


Secondary Outcome Measures :
  1. Safety and tolerability of SR low-dose GTN patches in the proposed patient population. [ Time Frame: 12 months ]
    Participant reported safety and tolerability as per FACT-P questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males;
  • Legal age of consent (18 years of age);
  • Histological evidence of adenocarcinoma of the prostate;
  • Patients have chosen watchful waiting or active surveillance as preferred management;
  • Patients have biochemical failure (defined below) after primary cancer treatment and prefer deferred cancer management:

    • Patients with an increasing PSA at least 3 months after surgery (at least two values above PSA 0.2 ng/mL);
    • Patients with a PSA 2 ng/ml above their nadir PSA after radiation therapy.

Exclusion Criteria:

  • Inability to provide an informed consent;
  • Inability to adhere to the study protocol for any reason;
  • Receiving any other adjuvant therapies for prostate cancer less than 6 months prior to study entry;
  • Any contraindication to GTN (including concomitant use of nitroglycerin formulations or phosphodiesterase inhibitors).

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 ClinicalTrials.gov identifier (NCT number): NCT01704274


Contacts
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Contact: Angela Black, RN CCRP 613 549 6666 ext 3848 blacka@kgh.kari.net
Contact: Janet Clark-Pereira, BA CCRP 613 548 7805 jmc2@queensu.ca

Locations
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Canada, Ontario
Centre for Applied Urological Research/Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Joe Downey, MSc CCRP    613 548 7832    downeyj@queensu.ca   
Principal Investigator: D. Robert Siemens, MD FRCSC         
Sub-Investigator: Michael Leveridge, MD FRCSC         
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: D. Robert Siemens, MD FRCSC Queen's University

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Responsible Party: Dr. D. Robert Siemens, PI, Queen's University
ClinicalTrials.gov Identifier: NCT01704274     History of Changes
Other Study ID Numbers: Protocol # CAUR 09
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013
Keywords provided by Dr. D. Robert Siemens, Queen's University:
biochemical
recurrence
prostate
cancer
active
surveillence
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes