Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UPCC-6899 NCI-T99-0042, NCT00005067, T99-0042

Objectives

Primary

1. Determine the dose limiting toxicities and maximum tolerated dose of photodynamic therapy (PDT) using 730 nm light and lutetium texaphyrin in patients with locally recurrent prostate adenocarcinoma who have failed previous definitive radiotherapy.

Secondary

1. Measure lutetium texaphyrin levels in needle biopsies of the prostate before and after PDT using an HPLC and tissue fluorescence assay and calculate the percent change in lutetium texaphyrin after treatment.
2. Measure lutetium texaphyrin fluorescence in situ in the prostate before and after PDT using optical methods and correlate these results with the direct tissue measurements made in the biopsies of these patients.
3. Determine clinical outcome including clinical response, progression free survival, time to complete response, time to biochemical relapse, time to local progression, time to distant failure, overall survival, and disease specific survival in these patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically proven locally recurrent prostate adenocarcinoma previously treated with definitive radiotherapy



• No T3 or T4 primary tumors



• No evidence of regional or distant metastases by MRI or bone scan



• No pathologic demonstration of malignancy in pelvic or abdominal lymph nodes



• Prostate gland volume no greater than 50 mL by MRI or ultrasound



• PSA no greater than 20 ng/mL

Prior/Concurrent Therapy:

Biologic therapy

• At least 4 weeks since prior gene therapy
• At least 4 weeks since prior immunotherapy

Chemotherapy

• At least 4 weeks since prior combination chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• At least 4 weeks since prior hormonal therapy
• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics

Surgery

• No prior cryosurgery for prostate cancer

Other

• No other concurrent medication for prostate cancer

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies)
• Bilirubin no greater than 1.5 mg/dL

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Other

• Medical suitability for implantation
• Fertile patients must use effective contraception during and for 6 months after study participation
• No history of grade III or IV genitourinary or gastrointestinal toxicity
• No known G6PD deficiency
• No porphyria

Expected Enrollment

A minimum of 24 patients will be accrued for this study within 3 years.

Outcomes

Dose-limiting toxicity and the maximum tolerated dose from the time of drug administration to 1 month

Lutetium texaphyrin levels in needle biopsies by high pressure liquid chromatography (HPLC) and tissue fluorescence assay before and after photodynamic therapy (PDT) and after surgery
Lutetium texaphyrin fluorescence by optical methods correlated to direct tissue measurements made in biopsies with HPLC and tissue fluorescence before and after PDT
Optical properties and absorption spectrum of the prostate by optical methods before and after PDT
Lutetium texaphyrin levels by HPLC and tissue fluorescence before and after PDT
Percentage of change in lutetium texaphyrin before and after PDT
Clinical response periodically until disease recurrence
Progression-free survival
Time to complete response
Time to biochemical relapse
Time to local progression
Time to distant failure
Overall survival
Disease specific survival
In-vivo tissue optical properties, photosensitizer concentration, tissue blood oxygenation, and blood flow by multi-modality optical instrument before, during, and after PDT

Outline

This is a dose-escalation study of lutetium texaphyrin and light fluence.

Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy (PDT). Optical fibers attached to a laser are inserted through a catheter into the prostate. The laser delivers 730 nm light to the prostate until the specified fluence is delivered. Patients undergo biopsy of the prostate and bladder before and after PDT.

Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed at 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years, then every 6 months for 3 years, and then annually thereafter.

Zhu TC, Finlay JC, Hahn SM: Determination of the distribution of light, optical properties, drug concentration, and tissue oxygenation in-vivo in human prostate during motexafin lutetium-mediated photodynamic therapy. J Photochem Photobiol B 79 (3): 231-41, 2005.[PUBMED Abstract]

Stripp DCH, Mick R, Zhu TC, et al.: Phase I trial of motexafin-lutetium-mediated interstitial photodynamic therapy in patients with locally recurrent prostate cancer. In: Proceedings of SPIE. 5315: 88, 2004.

Zhu TC, Dimofte A, Finlay JC, et al.: Optical properties of human prostate at 732 nm measured in mediated photodynamic therapy. Photochem Photobiol 81 (1): 96-105, 2005 Jan-Feb.[PUBMED Abstract]

Patel H, Mick R, Finlay J, et al.: Motexafin lutetium-photodynamic therapy of prostate cancer: short- and long-term effects on prostate-specific antigen. Clin Cancer Res 14 (15): 4869-76, 2008.[PUBMED Abstract]

Altschuler MD, Zhu TC, Li J, et al.: Optimized interstitial PDT prostate treatment planning with the Cimmino feasibility algorithm. Med Phys 32 (12): 3524-36, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

Stephen Michael Hahn, MD, Protocol chair		Ph: 215-662-7296 Email: hahn@xrt.upenn.edu

Registry Information
Official Title		A Phase I Trial of Photodynamic Therapy with Lutetium Texaphyrin in Patients with Locally Recurrent Prostate Carcinoma
Trial Start Date		2000-02-01
Registered in ClinicalTrials.gov		NCT00005067
Date Submitted to PDQ		2000-02-02
Information Last Verified		2007-01-15
NCI Grant/Contract Number		CA16520

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