Prostate CancerPR05NCT01040624
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
A study testing < 15% risk of + LN and > 15% risk of + LN in people with Prostate Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer. 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?
- < 15% risk of + LN and > 15% risk of + LN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adenocarcinoma of the prostate.
Who cannot join
- Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
- Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
- History of hip replacement.
- Prior intrapelvic surgery. This includes the following:
- Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
- Transabdominal pelvic surgery
Show all 9Show fewer
- Bladder surgery
- Prior myocardial infarction (MI) or congestive heart failure (CHF).
- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
- Conditions
- Prostate Cancer
- Being tested
- < 15% risk of + LN, > 15% risk of + LN
- Keywords
- Prostate Cancer, Proton Radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
< 15% risk of + LNRadiation
Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.
> 15% risk of + LNRadiation
Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| High-risk arm A (HR-A) | Experimental | < 15% risk of + lymph nodes (LN) Receives: Radiation: < 15% risk of + LN |
| HR-B | Experimental | > 15% risk of + LN Receives: Radiation: > 15% risk of + LN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
Measured: 6 months after the completion of radiation therapy
Secondary outcomes (2)
Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
Measured: After radiation: every 6 months for 3 years, then annually for 20 years
Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
Measured: After radiation: every 6 months for 3 years, then annually for 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2015
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy P Mendenhall, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040624
- Sponsor's protocol ID
- UFPTI 0703 - PR05
- Other IDs
- IRB201702459
- Acronym
- PR05
- Status last verified
- Sep 2023
- First submitted
- 24 Dec 2009
- Last updated
- 3 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Joint Committee on Cancer. AJCC Cancer Staging Handbook, 6th ed. New York: Springer Verlag; 2002.
Mendenhall NP, Li X, Morris CG, Keole S, Mendenhall WM, Nichols RC, Vargas C, Henderson RH, Early GI and GU toxicity in 3 prospective proton therapy trials for prostate cancer. Presented at the American Society of Therapeutic Radiation Oncologists. Chicago, 2009.
Aizer AA, Yu JB, McKeon AM, Decker RH, Colberg JW, Peschel RE. Whole pelvic radiotherapy versus prostate only radiotherapy in the management of locally advanced or aggressive prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1344-9. doi: 10.1016/j.ijrobp.2008.12.082. Epub 2009 May 21.
PubMed 19464821Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062.
PubMed 19577865Zelefsky MJ, Levin EJ, Hunt M, Yamada Y, Shippy AM, Jackson A, Amols HI. Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1124-9. doi: 10.1016/j.ijrobp.2007.11.044.
PubMed 18313526Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
PubMed 33532112D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
PubMed 9749478Cox JD, Kian AK. Mosby Radiation Oncology: Rationale, Technique, Results, 8th ed.C.V. Mosby; 2002.
Chism DB, Hanlon AL, Horwitz EM, Feigenberg SJ, Pollack A. A comparison of the single and double factor high-risk models for risk assignment of prostate cancer treated with 3D conformal radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):380-5. doi: 10.1016/j.ijrobp.2003.10.059.
PubMed 15145151Martinez AA, Demanes DJ, Galalae R, Vargas C, Bertermann H, Rodriguez R, Gustafson G, Altieri G, Gonzalez J. Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1322-31. doi: 10.1016/j.ijrobp.2004.12.053.
PubMed 16029788Roach M, Lu J, Pilepich MV, Asbell SO, Mohiuddin M, Terry R, Grignon D. Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):609-15. doi: 10.1016/s0360-3016(00)00578-2.
PubMed 10837943Anaya-Saavedra G, Ramirez-Amador V, Irigoyen-Camacho ME, Garcia-Cuellar CM, Guido-Jimenez M, Mendez-Martinez R, Garcia-Carranca A. High association of human papillomavirus infection with oral cancer: a case-control study. Arch Med Res. 2008 Feb;39(2):189-97. doi: 10.1016/j.arcmed.2007.08.003. Epub 2007 Nov 8.
PubMed 18164962Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8.
PubMed 11744442Makarov DV, Trock BJ, Humphreys EB, Mangold LA, Walsh PC, Epstein JI, Partin AW. Updated nomogram to predict pathologic stage of prostate cancer given prostate-specific antigen level, clinical stage, and biopsy Gleason score (Partin tables) based on cases from 2000 to 2005. Urology. 2007 Jun;69(6):1095-101. doi: 10.1016/j.urology.2007.03.042.
PubMed 17572194Soloway MS, Pareek K, Sharifi R, Wajsman Z, McLeod D, Wood DP Jr, Puras-Baez A; Lupron Depot Neoadjuvant Prostate Cancer Study Group. Neoadjuvant androgen ablation before radical prostatectomy in cT2bNxMo prostate cancer: 5-year results. J Urol. 2002 Jan;167(1):112-6.
PubMed 11743286
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01040624
- Acronym / sponsor ID
- PR05 / UFPTI 0703 - PR05
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Proton Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Posted 22 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk arm A (HR-A) | Experimental | Radiation: < 15% risk of + LN< 15% risk of + lymph nodes (LN) |
| HR-B | Experimental | Radiation: > 15% risk of + LN> 15% risk of + LN |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adenocarcinoma of the prostate.
Key exclusion criteria (9 listed)
- Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
- Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
- History of hip replacement.
- Prior intrapelvic surgery. This includes the following:
- Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
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 |
|---|---|---|
| < 15% risk of + LNTotal of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months. | Radiation | High-risk arm A (HR-A) |
| > 15% risk of + LNTotal of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months. | Radiation | HR-B |
Primary outcome
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
Time frame: 6 months after the completion of radiation therapy
Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
2 secondary outcomes
Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.
Time frame: After radiation: every 6 months for 3 years, then annually for 20 years
Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.
Time frame: After radiation: every 6 months for 3 years, then annually for 20 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAmerican Joint Committee on Cancer. AJCC Cancer Staging Handbook, 6th ed. New York: Springer Verlag; 2002.
- BackgroundMendenhall NP, Li X, Morris CG, Keole S, Mendenhall WM, Nichols RC, Vargas C, Henderson RH, Early GI and GU toxicity in 3 prospective proton therapy trials for prostate cancer. Presented at the American Society of Therapeutic Radiation Oncologists. Chicago, 2009.
- Background: PubMed 19464821Aizer AA, Yu JB, McKeon AM, Decker RH, Colberg JW, Peschel RE. Whole pelvic radiotherapy versus prostate only radiotherapy in the management of locally advanced or aggressive prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1344-9. doi: 10.1016/j.ijrobp.2008.12.082. Epub 2009 May 21.
- Background: PubMed 19577865Michalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062.
- Background: PubMed 18313526Zelefsky MJ, Levin EJ, Hunt M, Yamada Y, Shippy AM, Jackson A, Amols HI. Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1124-9. doi: 10.1016/j.ijrobp.2007.11.044.
- Background: PubMed 33532112Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
- Background: PubMed 9749478D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
- BackgroundCox JD, Kian AK. Mosby Radiation Oncology: Rationale, Technique, Results, 8th ed.C.V. Mosby; 2002.
- Background: PubMed 15145151Chism DB, Hanlon AL, Horwitz EM, Feigenberg SJ, Pollack A. A comparison of the single and double factor high-risk models for risk assignment of prostate cancer treated with 3D conformal radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):380-5. doi: 10.1016/j.ijrobp.2003.10.059.
- Background: PubMed 16029788Martinez AA, Demanes DJ, Galalae R, Vargas C, Bertermann H, Rodriguez R, Gustafson G, Altieri G, Gonzalez J. Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1322-31. doi: 10.1016/j.ijrobp.2004.12.053.
- Background: PubMed 10837943Roach M, Lu J, Pilepich MV, Asbell SO, Mohiuddin M, Terry R, Grignon D. Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys. 2000 Jun 1;47(3):609-15. doi: 10.1016/s0360-3016(00)00578-2.
- Background: PubMed 18164962Anaya-Saavedra G, Ramirez-Amador V, Irigoyen-Camacho ME, Garcia-Cuellar CM, Guido-Jimenez M, Mendez-Martinez R, Garcia-Carranca A. High association of human papillomavirus infection with oral cancer: a case-control study. Arch Med Res. 2008 Feb;39(2):189-97. doi: 10.1016/j.arcmed.2007.08.003. Epub 2007 Nov 8.
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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.
Nancy P Mendenhall, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing < 15% risk of + LN and > 15% risk of + LN in people with Prostate Cancer, run by University of Florida at 1 site 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acute Grade 3 or Higher Treatment-related Toxicity Rate. (time frame: 6 months after the completion of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040624, which also lists 53 linked publications.
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 3 Oct 2023.