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 : June 30, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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 3 months of treatment) and chronic (>3 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, distant recurrence, and survival
- Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be compared to prior literature.
- Evaluate feasibility of MRI BOLD/TOLD to be integrated as hypoxia monitoring sequences to standard already planned diagnostic and/or treatment planning MRI on the study in five patient pilot.
- 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.
|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, 2024|
|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).
- To compare the decline in patient health-related quality of life. [ Time Frame: Mean 24-Months ]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. 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 hormonal 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 & Chronic Genitourinary (GU) and Gastrointestinal (GI) toxicity [ Time Frame: Mean 24-Months ]Assess acute (within 3 months of treatment) and chronic (>3 months after treatment) SAbR related GU and GI toxicities, as well as serial impact on HRQOL metrics over time. Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. 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 progression free survival. [ Time Frame: 60 Months ]Assess biochemical progression free survival. Biochemical failure RTOG-ASTRO definition - when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.
- Time to local recurrence. [ Time Frame: 60 Months ]The time to progression will be measured from the date of study entry to the date of documented local progression as determined by clinical exam and/or MRI. Local progression is defined by progression within the prostate, seminal vesicles or immediately adjacent extracapsular soft tissue. Biopsy confirmation is not required but is encouraged.
- Time to distant recurrence. [ Time Frame: 60 Months ]The time to distant failure will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse. Patients with evidence of biochemical failure, but a negative prostate biopsy, will be considered as distant failure only.
- Overall survival. [ Time Frame: 60 Months ]The survival time will be measured from the date of accession to the date of death. All patients will be followed for survival. Every effort should be made to document the cause of death.
- Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints. [ Time Frame: Mean 24-Months ]Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be compared to prior literature. 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 hormonal 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Age ≥ 18 years.
- Appropriate staging studies identifying patient as AJCC 7th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. See Appendix I for details on AJCC 7th Edition staging criteria. Histologic confirmation of cancer will be required by biopsy performed within 12 months of registration. T-staging may be assessed by multi-parametric imaging alone if digital rectal examination was deferred.
- The patient's Zubrod performance status must be 0-2 (see Appendix II for definition).
- The Gleason summary score should be less than or equal to 7 [Grade group 1 (Gleason 3+3=6), group 2 (Gleason 3+4=7), and group 3 (Gleason 4+3=7) are allowed]. See Appendix III for details on definitions. While a template biopsy is recommended, it is not required in the case of MRI fusion biopsy performed on all dominant MR lesions (defined as PIRADS v2 4-5).
- Baseline AUA symptom score ≤19 (see Appendix IV for questionnaire) without need for maximum medical therapy (specifically, not on tamsulosin 0.8mg daily).
- EPIC sexual domain composite score 60-100 (see Appendix V).
- Multi-parametric MRI evaluation of the prostate is required for this study within 12 months of registration. Gross radiographic disease on MRI (defined as PIRADS v2 score 3-5) must be > 5mm at minimum distance from at least one side's neurovascular bundle, which is typically the closest of the neurovascular elements to the prostate.
The serum PSA should be less than or equal to 20 ng/ml within 90 days of registration.
-Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT or anti-androgen therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride; (5) within 5 days of a digital rectal examination (which is not a required exam on the protocol).
- Ultrasound or MRI based volume estimation of prostate gland ≤ 80 grams. Cytoreduction therapy (finasteride or dutasteride only) may be considered for those with >60 gram size.
- All patients must be willing and capable to provide informed consent to participate in the protocol within the 30 days prior to registration.
- Subjects with clinical (digital rectal examination) evidence of extraprostatic extension (T3a) or seminal vesicle involvement (T3b). MRI evidence of equivocal/potential but not definite extraprostatic extension is allowed, as long as it is unilateral and not on the side of the gland proposed for neurovascular element sparing. In equivocal cases of potential extracapsular extension on MRI only, discretion is left to the treating physician.
- MRI evidence of gross disease (defined as PIRADS v2 score 3-5 lesions) ≤5mm of BOTH neurovascular bundles, which are the most proximate of the neurovascular elements planned for sparing on this protocol.
- Patients with all three intermediate risk factors (PSA >10 and ≤ 20, Gleason 7, clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy cores positive for cancer are ineligible.
- Inability to undergo multi-parametric MRI.
- Evidence of metastatic disease. Note bone scan is not required for this study given the low-intermediate NCCN risk cohort to be enrolled.
- Evidence of clinical nodal involvement of the pelvis. Biopsy is required for lymph nodes over ≥1.5cm in short-axis measured size.
- No currently active ADT or anti-androgen therapy at time of registration is allowed. Further, no more than 3 cumulative months of prior ADT or anti-androgen therapy is allowed. If either has been used by the patient, there must be a demonstration of testosterone recovery (>50ng/dL serum blood level), EPIC sexual domain score ≥60, and at least 1 month between demonstration of testosterone recovery and study registration (any one measurement of testosterone recovery suffices).
- Testosterone ≤ 50 ng/dL (any one measurement >50 ng/dL suffices for inclusion) within 90 days of study entry.
- Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery for prostate cancer.
- Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer.
- Subjects who have undergone previous transurethral resection of the prostate (TURP) within 1 year of enrollment or ablative procedures to the prostate for benign prostatic hyperplasia or other conditions (i.e. cryotherapy, HIFU).
- Subjects who have baseline severe urinary symptoms, as defined by AUA symptom score >19 (alpha-blocker medication allowed except if taking tamsulosin 0.8mg daily at baseline which indicates compensated severe symptoms and also can affect sexual function).
- Subjects who have a history of significant psychiatric illness that would confound informed consent.
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
- Patients with active inflammatory colitis (including Crohn's Disease and ulcerative colitis) currently requiring systemic steroids and/or systemic immunosuppression are not eligible.
- Subjects with a known allergy to polyethylene glycol hydrogel (rectal spacer material) or contraindication to spacer products (SpaceOAR).
- Subjects with uncontrolled coagulation disorder which cannot be controlled with anticoagulants.
- Men active with partners of reproductive potential who do not agree that they will use an effective contraceptive method during treatment and 6 months after treatment.
- Men who require erectile function medication or aid to achieve an erection sufficient for intercourse. Ability to achieve erection sufficient for intercourse without medication or aid at least once time in the month prior to registration is sufficient for inclusion.
- Men who have clinically significant penile malformation (i.e. Peyronie's disease) or history of penile implantation are excluded.
- If DRE is performed, patient may not have palpable disease on side of gland to be planned for neurovascular sparing. Given the poor accuracy of DRE, such a finding should be confirmed by MRI and/or biopsy to harbor actual disease before excluding a patient on this basis.
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: Sarah Neufeld||2146481836||Sarah.Neufeld@utsouthwestern.edu|
|United States, California|
|UCSF ( Department of Radiation Oncology University of California San Francisco)||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Jamese Johnson 415-353-7175 Jamese.Johnson@ucsf.edu|
|Principal Investigator: Osama Mohamad, MD|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Amanda Pollock 720-848-8787 Amanda.firstname.lastname@example.org|
|Principal Investigator: Tyler Robin, MD|
|Colorado Springs, Colorado, United States, 80907|
|United States, Michigan|
|University of Michigan- Michigan Medicine||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Katie Donovan 734-764-3685 email@example.com|
|Principal Investigator: Robert Dess, MD|
|United States, New York|
|Stony Brook University Cancer Center||Recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Catherine Izzo 631-444-4392 firstname.lastname@example.org|
|Principal Investigator: Alexander Slade, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Stephanie Chung 216-445-8285 CHUNGS3@ccf.org|
|Principal Investigator: Kevin Stephans, MD|
|United States, Pennsylvania|
|Penn Medicine Radiation Oncology||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Susan Mazzoni 800-789-7366 email@example.com|
|Principal Investigator: John Christodouleas, MD|
|United States, Texas|
|UT Southwestern Cancer Center||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Sarah Neufeld 214-648-1836 Sarah.Neufeld@utsouthwestern.edu|
|Responsible Party:||Neil Desai, Associate Professor of Medicine, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||May 15, 2018 Key Record Dates|
|Last Update Posted:||June 30, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Erectile dysfunction, Neurovascular, Prostate, Rectal spacer, Radiotherapy
Genital Neoplasms, Male
Neoplasms by Site