Clinical trial · Interventional
Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
This phase I trial is studying the side effects and best dose of photodynamic therapy with lutetium texaphyrin in treating patients with locally recurrent prostate cancer. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for locally recurrent prostate cancer. Photosensitizing drugs, such as lutetium texaphyrin, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| motexafin lutetium | Drug | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (motexafin lutetium, PDT)
- description
- 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.
- interventionNames
- Drug: motexafin lutetium
- Drug: photodynamic therapy
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT) defined as grade III non-hematologic toxicity or grade IV hematologic toxicity as assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 2.0
- timeFrame
- 24 hours
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Performance status - ECOG 0-2 * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies) * Bilirubin no greater than 1.5 mg/dL * Creatinine normal * Creatinine clearance at least 60 mL/min * 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 * At least 4 weeks since prior gene therapy * At least 4 weeks since prior immunotherapy * At least 4 weeks since prior combination chemotherapy * No concurrent chemotherapy * At least 4 weeks since prior hormonal therapy * No concurrent hormonal therapy * No prior cryosurgery for prostate cancer * No other concurrent medication for prostate cancer
References
Publications (0)
Data not yet available