Cancer of the PROSTATE Clinical Trial
Official title:
Vessel Sparing Prostate Radiation Therapy: Dose Limitation to Critical Erectile Structures (Corpus Cavernosum and Internal Pudendal Artery) by MRI Based Treatment Planning
Verified date | February 2018 |
Source | University of Michigan Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prostate cancer patients have a number of excellent treatment options to consider, and quality of life following treatment is often a consideration in treatment choice. One critical quality of life concern for patients diagnosed with prostate cancer is sexual function. Previous studies point to a vascular mechanism of impotence post-radiation therapy, as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging and included in treatment planning for radiation treatments, hopefully preserving critical artery function. This study will collect erectile function preservation rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient reported using the simplified three-question erectile function scale.
Status | Completed |
Enrollment | 135 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed diagnosis of prostate cancer - Patients must have measurable erectile function. Patients with erectile function on Viagra and drugs of the same class are eligible. Patients who require 6 months of hormonal therapy or less are eligible, provided baseline erectile function is measured prior to or within 14 days of the start of hormonal therapy. - Baseline PSA (Prostate Specific Antigen), TNM stage (a classification of malignant tumors in cancer), and Gleason Score (A system of grading prostate cancer tissue based on how it looks under a microscope): Patients with low (PSA less than 10, T2a or less, Gleason 6 or less), intermediate, or high (Gleason 8-10, T3a, PSA over 20) risk disease are eligible for this protocol. Patients on finasteride or drugs of the same class are eligible. - Patients must be 18 years or older. No upper age restriction. - Patients treated with external beam radiotherapy alone or external beam therapy plus implant therapy are eligible. - Patients must have an ECOG (Eastern Cooperative Oncology Group system of grading patient status that attempts to quantify cancer patients' general well-being and activities of daily life) performance status <2. - The patient must sign study specific informed consent approved by the IRB of U of M indicating they are aware of the investigational nature of the treatment. Exclusion Criteria: - Patients who are impotent or have an IIEF (International Index of Erectile Function) <16. - Patients who are medically ineligible for radiation therapy due to other medical conditions. - Patients given hormonal therapy before baseline questionnaires filled out. - Patients who receive implant only therapy. - Patients unable to undergo MRI (Magnetic Resonance Imaging). |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids | The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: Sexually active without aids Sexually active with aids Not sexually active with or without aids |
5 years from end of radiation treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03653819 -
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
|
N/A | |
Withdrawn |
NCT05191017 -
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
|
Phase 1/Phase 2 | |
Completed |
NCT00970203 -
Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer
|
Phase 2 | |
Not yet recruiting |
NCT06363266 -
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
|
N/A | |
Active, not recruiting |
NCT02003924 -
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
|
Phase 3 | |
Completed |
NCT00643617 -
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
|
N/A | |
Completed |
NCT00844792 -
Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Completed |
NCT01303705 -
Anti-OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer
|
Phase 1 | |
Completed |
NCT02578940 -
Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer
|
Phase 3 | |
Completed |
NCT04057859 -
PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training
|
||
Completed |
NCT00564928 -
A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
|
Phase 2 | |
Completed |
NCT01897207 -
Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Hormone-Refractory Prostate Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05241236 -
MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer
|
||
Active, not recruiting |
NCT03939689 -
Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone
|
Phase 2 | |
Completed |
NCT02274350 -
The Herlev Hospital Post Radiation Therapy for Localized Prostate Cancer Database for Sexual Side Effects
|
N/A | |
Completed |
NCT00744549 -
Study of Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance
|
Phase 2 | |
Recruiting |
NCT05252390 -
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT02212548 -
Prostate-Rectal Separation With PEG Hydrogel and Its Effect on Decreasing Rectal Dose
|
N/A | |
Completed |
NCT04017325 -
European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up
|
||
Active, not recruiting |
NCT03238170 -
MR-simulation in Radiotherapy for Prostate Cancer
|
N/A |