Prostate Cancer Clinical Trial
Official title:
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
The primary purpose of this study is to compare the quality of life (QOL) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy [SBRT]) versus the self-reported QOL of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).
Status | Recruiting |
Enrollment | 136 |
Est. completion date | November 2029 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men age = 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA = 0.1 ng/mL - Interval between prostatectomy and planned radiation therapy start date = 6 months - KPS = 70 - Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are = 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy) - Ability to complete the EPIC-26 quality of life questionnaire - Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology - Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: - Prior history of pelvic radiation therapy - History of moderate/severe or active Crohn's disease or ulcerative colitis - History of bladder neck or urethral stricture - Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels - Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy - History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer - Any condition that in the opinion of the investigator would preclude participation in this study |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Rogel Cancer Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Rogel Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline | GI and GU QOL assessed with the EPIC-26 questionnaire, bowel and urinary domains. Change scores will be calculated as baseline score subtracted from 2-year score. All patients with EPIC bowel and urinary domain scores will be included in the primary endpoint analysis. The EPIC scoring manual will be followed which requires = 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score >96, low bowel score <= 96, high urinary score > 84, low urinary score <=84. | 2-years post-treatment | |
Secondary | Patient reported GU quality of life (QOL) up to 60 months | GU QOL assessed with the EPIC-26 questionnaire, urinary domain; at the end of radiation, 3, 6, 12, and 60 months post-treatment. The EPIC scoring manual will be followed which requires = 80% of items in a domain to be completed in order to obtain a score for that domain. High urinary score > 84, low urinary score <=84. A longitudinal analysis incorporating all follow-up time points, will be conducted separately for each domain score. | 60 months post-treatment | |
Secondary | Patient reported GI quality of life (QOL) up to 60 months | GI QOL assessed with the EPIC-26 questionnaire, bowel domain; at the end of radiation, 3, 6, 12, and 60 months post-treatment. The EPIC scoring manual will be followed which requires = 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score >96, low bowel score <= 96. A longitudinal analysis incorporating all follow-up time points, will be conducted separately for each domain score. | 60 months post-treatment | |
Secondary | Treatment related toxicity - acute | Treatment related toxicity (adverse events) assessed with CTCAE version 5.0 | = 90 days after treatment completion | |
Secondary | Treatment related toxicity - late | Treatment related toxicity (adverse events) assessed with CTCAE version 5.0 | >90 days after treatment completion, up to 5 years | |
Secondary | Time to progression | Time to progression (where progression is defined as the first occurrence of biochemical failure, local failure, regional failure, distant metastasis, start of salvage therapy, or death from prostate cancer) | up to 5 years | |
Secondary | Rate of biochemical failure | Biochemical failure will be assessed using two definitions. Definition one is a PSA = 0.4 ng/mL followed by a second higher value. Definition two is the post-radiation PSA nadir + 2ng/mL | up to 5 years | |
Secondary | Local failure, Regional failure, Distant metastases | Descriptive statistics will be used to describe the number of local, regional and distant metastases. Local failure is defined as development of a new biopsy-proven mass or prostate specific PET avid mass in the prostate bed after completion of protocol treatment Regional failure is defined as radiographic evidence of pelvic lymphadenopathy (lymph node size = 1.5 cm in short axis) or PET avid lymph nodes within the pelvis following protocol treatment Distant metastases is defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer |
up to 5 years | |
Secondary | Prostate cancer specific survival | Prostate cancer specific survival defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the date of last known follow-up or date of death, respectively. | up to 5 years | |
Secondary | Overall survival | Overall survival defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the date of last known follow-up. | up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |