Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C) (POTEN-C)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03525262|
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : July 10, 2020
Reduction of dose to or 'sparing' of neurovascular structures during stereotactic ablative body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual potency, while retaining excellent oncologic control and other secondary health-related quality of life (HRQOL) endpoints.
• To compare the decline in patient health-related quality of life (HRQOL) instrument-defined erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing
- Assess acute (within 9 months of treatment) and chronic (>9 months after treatment) SAbR related GU and GI toxicities, as well as serial impact on HRQOL metrics over time
- Assess biochemical progression free survival, local recurrence, disease-specific survival
- Evaluate the impact of neurovascular sparing on neurovascular element dose and the impact of rectal spacer use on neurovascular element sparing
- Evaluate quality of spacer placement and its effect on dose to neurovascular structures
- Evaluate rate local recurrence in the area of sparing adjacent to the neurovascular elements by biopsy in those with biochemical progression.
- Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be compared to prior literature.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Adenocarcinoma||Radiation: 30Gy (Gray) planning target volume (PTV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Controlled Trial of Stereotactic Ablative Body Radiotherapy (SAbR) With or Without Neurovascular Sparing for Erectile Function Preservation in Localized Prostate Cancer|
|Actual Study Start Date :||April 24, 2018|
|Estimated Primary Completion Date :||June 16, 2022|
|Estimated Study Completion Date :||June 16, 2024|
No Intervention: SAbR WITHOUT Neurovascular sparing
Experimental: SAbR WITH Neurovascular sparing
Radiation: 30Gy (Gray) planning target volume (PTV)
PTV1_30Gy represents a 3mm expansion on the prostate (and proximal seminal vesicle per physician discretion), excluding the neurovascular structures on the side to be spared (left or right). PTV1 will receive 6 Gy per fraction for 5 fractions (30 Gy).
- Reduction in Expanded prostate cancer index composite (EPIC) sexual function domain composite score from Baseline [ Time Frame: Mean 24-Months ]The Expanded prostate cancer index composite (EPIC) Health-related quality of life (HRQOL) instrument includes four sub-scales like Urinary function, Bowel habits, Sexual function, and Harmonal function. The primary outcome (sexual function) which has a range score of 0-100 from 9 questions related to ability to achieve an erection with or without aids and participate in intercourse. Higher the score represents the better outcome. Individual responses are summed for a total score of sexual function.
- Acute & Delayed Genitourinary (GU) and Gastrointestinal (GI) toxicity [ Time Frame: Mean 24-Months ]Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Dose adjustments should be made according to the system showing the greatest degree of toxicity. The consequences of gastointestinal/renal/genitourinary/sexual and reproductive toxicity should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE), version 4.0 occurring prior to 270 days from the start of protocol treatment. Other treatment related toxicity attributed to the therapy will be captured, recorded and the consequences of should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE). CTCAE V4.0 along with grades 1-5 is provided in the link for reference (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf).
- Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition) [ Time Frame: 60 Months ]Increase in PSA greater than 2ng/ml above the patients lowest PSA level (nadir) after treatment.
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): NCT03525262
|Contact: Neil B Desai, MD MHS||2146458525||Neil.Desai@UTSouthwestern.edu|
|Contact: Samantha Mannalafirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Robyn Swing 720-848-0607 Robyn.email@example.com|
|Principal Investigator: Thomas Pugh, MD|
|United States, Texas|
|UT Southwestern Cancer Center||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Samantha Mannala 214-648-1873 firstname.lastname@example.org|