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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
Placebo Comparator: 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
- 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.
- 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
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
|Contact: Angela Black, RN CCRP||613 549 6666 ext firstname.lastname@example.org|
|Contact: Janet Clark-Pereira, BA CCRP||613 548 email@example.com|
|Centre for Applied Urological Research/Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L 2V7|
|Contact: Joe Downey, MSc CCRP 613 548 7832 firstname.lastname@example.org|
|Principal Investigator: D. Robert Siemens, MD FRCSC|
|Sub-Investigator: Michael Leveridge, MD FRCSC|
|Principal Investigator:||D. Robert Siemens, MD FRCSC||Queen's University|