Prostate Cancer Clinical Trial
Official title:
Ablative Therapy in the Management of Prostate Cancer
The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2039 |
Est. primary completion date | March 2032 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >18 years of age - Undergoing focal therapy for primary or salvage treatment of prostate cancer, or - Have received prior focal therapy Exclusion Criteria: - Clinically-evident metastatic disease - Unable to fill out an English-language questionnaire |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | OPKO Diagnostics, LLC, Prostate Cancer Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prostate biopsy Gleason grade | Will be obtained through patient biopsy pathology results | 12 months | |
Secondary | Patient characteristics/demographics | Will be obtained through patient medical history in electronic health record | 12 months | |
Secondary | MRI PI-RAD grade | Will be obtained through patient MRI radiology results | 12 months | |
Secondary | Lab results - PSA level | Will obtain patient PSA (ng/mL) through laboratory (blood) results | 12 months | |
Secondary | Patient-reported quality of life: EPIC-26 | Expanded Prostate Cancer Index Composite (short form) questionnaire to assess quality of life | 12 months | |
Secondary | Patient-reported quality of life: IIEF-5 | The International Index of Erectile Function questionnaire to assess erectile function | 12 months | |
Secondary | Patient-reported quality of life: MSHQ-EjD | Male Sexual Health questionnaire to assess ejaculatory function | 12 months | |
Secondary | Patient-reported quality of life: IPSS | International Prostate Symptom Score questionnaire to assess urinary function and quality of life | 12 months |
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