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Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy

Primary Purpose

Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
WST09
Sponsored by
STEBA France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

- Inclusion Criteria: 18 years of age or older Ability to understand the patient's information sheet and to give written informed consent Histologic proof of adenocarcinoma of the prostate 12 months or longer following definitive radiotherapy Disease confined to the prostate (stage T1-N0 or X-M0 or X or T2-N0 or X -M0 or X) without evidence of regional and/or distant disease Recent (within 90 days) CT scan of the abdomen and pelvis and radionucleotide bone scan or equivalent radiographic imaging confirming that no disease is outside of the prostate Recent (within 3 months) cystoscopy if clinically warranted Serum prostatic specific antigen (PSA) equal to or less than 20 ng/mL Serum PSA showing two consecutive increases at least 2 weeks apart Life expectancy more than 5 years, based on co-morbidity not related to prostate cancer Ability to comply with the requirements of the study - Exclusion Criteria: Patients who are currently receiving any hormone treatment for prostatic carcinoma or for any other cancer, or have done so within the last 6 months. Patients who have received or are receiving chemotherapy for prostatic carcinoma or for any other cancer Patients who are currently receiving any photosensitizing medications (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin) Patients who have received a TURP (trans-urethral resection of the prostate) Patients whose radiation therapy caused extensive cystitis and/or proctitis Any condition, or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions) History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires Participation in a clinical study or receipt of an investigational treatment within the past 90 days A history of porphyria A history of significant allergies, particularly to Cremophor® and Benadryl® A history of sun hypersensitivity or photosensitive dermatitis Renal disorders (blood creatinine > 1.5 x ULN) Hepatic disorders (transaminases > ULN, bilirubin> ULN) Hematological disorders: (White cells < 2500/mm3, neutrophil< 1500/mm3, platelets <140,000/mm3, Hb < 8 g/dl)

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WST 09

Arm Description

Treatment with WST09 Vascular Photodynamic therapy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 28, 2006
Last Updated
June 18, 2010
Sponsor
STEBA France
Collaborators
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00308919
Brief Title
Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy
Official Title
Phase II Study of Photodynamic Therapy With WST-09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure : Effect of the Light Dose and the Number of Fibres
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
STEBA France
Collaborators
University Health Network, Toronto

4. Oversight

5. Study Description

Brief Summary
To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in patients with recurrent or persistent localized prostate cancer following definitive radiotherapy using different light doses and multiple illuminating fibres.
Detailed Description
Prostate cancer is a leading cause of morbidity and mortality in men around the world. Because of the worldwide increase in life expectancy, a dramatic increase in the number of patients with prostate cancer is expected. It has been estimated that by the year 2002, 92,000 men over 65 years of age were diagnosed annually in the European community, where prostate cancer will account for 12% of all new male cancer diagnoses. Consequently, radiation therapy is used extensively for primary therapy of prostatic carcinoma. The Management Report of clinically localized prostate cancer by the National Cancer Institute SEER program indicated that 30% of patients choose radiation therapy as their first treatment option. However, the ability of radiation therapy to totally and permanently eradicate prostatic cancer has come under question recently as a result of the high number of patients who have post radiotherapy elevated prostatic specific antigen (PSA) determinations (85%), and the high positive post irradiation biopsy rate (31 90%). With high local recurrence rates possibly influencing death rates, the recurrence of prostate cancer after potentially curative local therapy is becoming a significant urological problem. As patients are being treated for prostate cancer at a younger age, a significant number of them will ultimately fail the primary treatment and will be candidates for safe and potentially curative salvage therapy. High complication and morbidity rates associated with current salvage therapies demand new and improved means for eradicating recurrent local disease. Photodynamic therapy, which allows the destruction of a tumor by the IV administration of a photosensitizer and the local application of light, may provide such means. Transperineal interstitial photodynamic therapy is a minimally invasive procedure to treat selected patients with failed radiation therapy of prostate cancer. A preliminary phase 1 study using the photosensitizer meso-tetrahydroxyphenyl chlorine (mTHPC) in 14 patients indicated that PDT could produce necrosis in prostate involving cancers recurring after radiotherapy, with a low incidence of complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WST 09
Arm Type
Experimental
Arm Description
Treatment with WST09 Vascular Photodynamic therapy
Intervention Type
Drug
Intervention Name(s)
WST09
Intervention Description
Treatment with WST09 Vascular Photodynamic therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
- Inclusion Criteria: 18 years of age or older Ability to understand the patient's information sheet and to give written informed consent Histologic proof of adenocarcinoma of the prostate 12 months or longer following definitive radiotherapy Disease confined to the prostate (stage T1-N0 or X-M0 or X or T2-N0 or X -M0 or X) without evidence of regional and/or distant disease Recent (within 90 days) CT scan of the abdomen and pelvis and radionucleotide bone scan or equivalent radiographic imaging confirming that no disease is outside of the prostate Recent (within 3 months) cystoscopy if clinically warranted Serum prostatic specific antigen (PSA) equal to or less than 20 ng/mL Serum PSA showing two consecutive increases at least 2 weeks apart Life expectancy more than 5 years, based on co-morbidity not related to prostate cancer Ability to comply with the requirements of the study - Exclusion Criteria: Patients who are currently receiving any hormone treatment for prostatic carcinoma or for any other cancer, or have done so within the last 6 months. Patients who have received or are receiving chemotherapy for prostatic carcinoma or for any other cancer Patients who are currently receiving any photosensitizing medications (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin) Patients who have received a TURP (trans-urethral resection of the prostate) Patients whose radiation therapy caused extensive cystitis and/or proctitis Any condition, or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions) History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires Participation in a clinical study or receipt of an investigational treatment within the past 90 days A history of porphyria A history of significant allergies, particularly to Cremophor® and Benadryl® A history of sun hypersensitivity or photosensitive dermatitis Renal disorders (blood creatinine > 1.5 x ULN) Hepatic disorders (transaminases > ULN, bilirubin> ULN) Hematological disorders: (White cells < 2500/mm3, neutrophil< 1500/mm3, platelets <140,000/mm3, Hb < 8 g/dl)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Trachtenberg, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17507719
Citation
Haider MA, Davidson SR, Kale AV, Weersink RA, Evans AJ, Toi A, Gertner MR, Bogaards A, Wilson BC, Chin JL, Elhilali M, Trachtenberg J. Prostate gland: MR imaging appearance after vascular targeted photodynamic therapy with palladium-bacteriopheophorbide. Radiology. 2007 Jul;244(1):196-204. doi: 10.1148/radiol.2441060398. Epub 2007 May 16.
Results Reference
derived

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Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy

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