Prostate AdenocarcinomaNCT01352429
Mild Hypofractionation With Proton Therapy or IMRT for Intermediate-Risk Prostate Cancer
An observational study of Prostate Adenocarcinoma, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Proton Therapy and IMRT
- Type of treatment
- Surgery or procedure
- How many people
- 303 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with non-metastatic adenocarcinoma of the prostate, presenting for definitive proton or photon radiotherapy of the prostate.
Who may be able to join
- Histologically confirmed prostate adenocarcinoma within 365 days of registration.
- Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node > 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with > 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)
- PSA values <20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
- Zubrod (ECOG) status 0-1 documented within 90 days of registration.
- Androgen deprivation is at the discretion of the treating radiation oncologist.
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- Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.
- Subjects must be at least 18 years old.
- Members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Clinical stages T3 or greater (AJCC Criteria 6th Ed).
- PSA of 20 ng/ml or greater.
- Gleason score 8 or higher.
- Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
- Evidence of lymph node involvement.
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.
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- Previous pelvic radiation for prostate cancer.
- Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.
- Prior systemic chemotherapy for prostate cancer.
- History of proximal urethral stricture requiring dilatation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate -Risk Adenocarcinoma of the Prostate
This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.
Read the detailed description
This study will be done in two phases, first, a feasibility study and then a registration study. In the first, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Proton Therapy, IMRT
- Keywords
- adult, histologically confirmed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton TherapyRadiation
IMRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Feasibility | Not described Receives: Radiation: Proton Therapy; Radiation: IMRT | |
| Phase 2 Registration | Not described Receives: Radiation: Proton Therapy; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
Measured: Within 10 days
Acute Toxicity
Any grade 2 or higher GI or GU toxicity, other than GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU. In the feasibility phase of this trial, the observation window for acute toxicty is extended to 60 days from completion of radiotherapy, as a feasibility precaution.
Measured: Within 60 days of completion of radiotherapy
Secondary outcomes (2)
Late toxicity
Any grade 2 or higher GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU which occurs beyond 60 days from completion of radiotherapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system.
Measured: open-ended
Biochemical/clinicalprogression-free survival
The time from start of radiotherapy to either documented increase in PSA or clinical progression of disease (based on CT, MRI, or bone scan), death due to any cause or last patient contact alive.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Vapiwala, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352429
- Sponsor's protocol ID
- UPCC 18809
- Status last verified
- Jul 2026
- First submitted
- 5 May 2011
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate -Risk Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT01352429
- Acronym / sponsor ID
- UPCC 18809
- Conditions
- Prostate Adenocarcinoma
- Keywords
- adult, histologically confirmed
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 May 2011 (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 is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.
Detailed description
This study will be done in two phases, first, a feasibility study and then a registration study. In the first, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Feasibility | – | Radiation: Proton Therapy, Radiation: IMRT |
| Phase 2 Registration | – | Radiation: Proton Therapy, Radiation: IMRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-metastatic adenocarcinoma of the prostate, presenting for definitive proton or photon radiotherapy of the prostate.
Key inclusion criteria (9 listed)
- Histologically confirmed prostate adenocarcinoma within 365 days of registration.
- Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node > 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with > 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)
- PSA values <20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
- Zubrod (ECOG) status 0-1 documented within 90 days of registration.
Key exclusion criteria (10 listed)
- Clinical stages T3 or greater (AJCC Criteria 6th Ed).
- PSA of 20 ng/ml or greater.
- Gleason score 8 or higher.
- Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
- Evidence of lymph node involvement.
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 |
|---|---|---|
| Proton Therapy | Radiation | Phase 1 Feasibility, Phase 2 Registration |
| IMRT | Radiation | Phase 1 Feasibility, Phase 2 Registration |
Primary outcome
Number of Participants with Adverse Events
Time frame: Within 10 days
Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.
Acute Toxicity
Time frame: Within 60 days of completion of radiotherapy
Any grade 2 or higher GI or GU toxicity, other than GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU. In the feasibility phase of this trial, the observation window for acute toxicty is extended to 60 days from completion of radiotherapy, as a feasibility precaution.
2 secondary outcomes
Late toxicity
Time frame: open-ended
Biochemical/clinicalprogression-free survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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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.
Neha Vapiwala, MD principal investigator
Abramson Cancer Center at Penn Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma, run by Abramson Cancer Center at Penn Medicine 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Within 10 days). The study lists 2 primary outcomes in all. 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 22 Jul 2026.