Prostate CancerNCT02040610
Hypofractionated Image Guided Proton Therapy for Low andIntermediate Risk Prostate Cancer
A study testing Hypofractionated Proton Therapy in people with Prostate Cancer, run by Provision Center for Proton Therapy at 2 sites in United States.
Trial summary
This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated Proton Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological (histologically) proven diagnosis of prostatic adenocarcinoma within 365 days (1 year) prior to study registration.
- History and physical exam with digital rectal exam of the prostate to establish clinical staging
- Clinical stage T1-T2c (AJCC 7th edition) within 90 days of registration.
- Prostate specific antigen (PSA) < 20 ng/mL within 90 days prior to registration.
- Gleason Score < 7.
- Eastern Cooperative Oncology Group(ECOG) Performance status 0-1.
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- Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan).
- Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤ 1.5 cm in diameter; any node larger than this on imaging will require negative biopsy for eligibility, unless the node is know to be enlarged from prior scans and considered stable, per discretion of the treating physician.
- Patients must be 18 years of age or older.
- Patient must be able to provide study-specific informed consent prior to study entry.
- Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire.
- No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
- Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
- Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
- Patient is able to start proton therapy or neo-adjuvant hormonal therapy, when recommended, within 12 weeks of registration.
- No prior radiotherapy to the pelvic area.
- No prior prostate cancer therapy such as: prostatectomy, cryotherapy, chemotherapy or hyperthermia.
- Platelets ≥ 100,000 cells/mm3, Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3, Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- Obs.: Patients with high risk factors, such as T3, Gleason 8-10 or PSA > 20ng/mL who are not considered candidates for pelvic lymph node radiation treatment are still considered eligible for this study.
Who cannot join
- • Prior radiotherapy to the pelvic area.
- Prior prostate cancer therapy such as: prostatectomy, cryotherapy, or hyperthermia.
- Prior systemic therapy (chemotherapy) for prostate cancer.
- Evidence of distant metastases.
- Regional lymph node involvement.
- Previous or concurrent cytotoxic chemotherapy for prostate cancer.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition. Note however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Provision Cares Proton Therapy Center Knoxville
Knoxville, Tennessee, 37909
Natalie E Freeman, PhD, 8659342672, natalie.freeman@biomed-research.com
Brenda Whitehead, CCRP, 8652433278, wil.rivers@biomed-research.com
- Recruiting
Provision Cares Proton Therapy Center Nashville
Nashville, Tennessee, 37067
Natalie E Freeman, PhD, 865-934-2672, natalie.freeman@biomed-research.com
Wil J Rivers, BS, 6157164736, wil.rivers@biomed-research.com
About this study
Official title: A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer
This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Read the detailed description
Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated Proton Therapy
- Keywords
- Low Risk Prostate Cancer, Intermediate Risk Prostate Cancer, Hypofractionated, Image Guided Proton Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Proton TherapyRadiation
Also called Proton Therapy
| Study group | Role | What they receive |
|---|---|---|
| Low Risk Prostate Cancer | Active comparator | Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks Receives: Radiation: Hypofractionated Proton Therapy |
| Intermediate Risk Prostate Cancer | Active comparator | Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks Receives: Radiation: Hypofractionated Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to biochemical failure
To determine the freedom from biochemical failure survival outcomes (FFBF) and compare to historical FFBF results achieved following standard fractionation proton therapy
Measured: 5 years
Secondary outcomes (2)
Toxicity Assessment
To determine the incidence of acute and late Gastrointestinal and Genitourinary toxicity at 2 and 5 years.
Measured: 2 years & 5 years
Analyze Quality of Life
To assess quality of life following proton therapy (QOL EPIC) at 2 and 5 years
Measured: 2 years & 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Provision Center for Proton Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Biomedical Research, LLC
- Responsible party
- Sponsor
- Investigators
- J. Ben Wilkinson, M.D., Principal investigator, Provision Center for Proton Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040610
- Sponsor's protocol ID
- PRO 1401
- Status last verified
- Apr 2019
- First submitted
- 16 Jan 2014
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02040610
- Acronym / sponsor ID
- PRO 1401
- Conditions
- Prostate Cancer
- Keywords
- Low Risk Prostate Cancer, Intermediate Risk Prostate Cancer, Hypofractionated, Image Guided Proton Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Provision Center for Proton TherapyUniversity, hospital or other
- Collaborators
- Center for Biomedical Research, LLC
- Study start
- Jan 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Detailed description
Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk Prostate Cancer | Active comparator | Radiation: Hypofractionated Proton TherapyHypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks |
| Intermediate Risk Prostate Cancer | Active comparator | Radiation: Hypofractionated Proton TherapyHypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Pathological (histologically) proven diagnosis of prostatic adenocarcinoma within 365 days (1 year) prior to study registration.
Key exclusion criteria (7 listed)
- • Prior radiotherapy to the pelvic area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Proton TherapyAlso: Proton Therapy | Radiation | Intermediate Risk Prostate Cancer, Low Risk Prostate Cancer |
Primary outcome
Time to biochemical failure
Time frame: 5 years
To determine the freedom from biochemical failure survival outcomes (FFBF) and compare to historical FFBF results achieved following standard fractionation proton therapy
2 secondary outcomes
Toxicity Assessment
Time frame: 2 years & 5 years
Analyze Quality of Life
Time frame: 2 years & 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Ben Wilkinson, M.D. principal investigator
Provision Center for Proton Therapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Proton Therapy in people with Prostate Cancer, run by Provision Center for Proton Therapy at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie E Freeman, PhD (8659342672, natalie.freeman@biomed-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to biochemical failure (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.