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RecruitingNCT00969111Updated Jun 17, 2026

Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

An interventional study of IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE and Proton (prostate bed) to 70.2 CGE in Prostate Cancer, sponsored by Proton Collaborative Group. Recruiting at 6 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Proton Collaborative Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • Proton Radiation, Prostate Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
  • Maximum PSA value of 20 ng/ml.

Exclusion criteria

Exclusion Criteria:

  • Evidence of distant metastasis (M1).
  • Prior systemic chemotherapy for any reason.
  • Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Postop Non-High Risk

    Proton to 66.6 CGE

    Radiation: Proton to 66.6 CGE

  • Experimental
    Postop High Risk

    IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

    Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

  • Experimental
    Salvage Non-High Risk

    Proton to 70.2 CGE

    Radiation: Proton (prostate bed) to 70.2 CGE

  • Experimental
    Salvage High Risk

    IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

    Radiation: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

Interventions

  • RadiationIMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

    Postop High Risk

  • RadiationProton (prostate bed) to 70.2 CGE

    Salvage Non-High Risk

  • RadiationIMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

    Salvage High Risk

  • RadiationProton to 66.6 CGE

    Post-Op Non High Risk

05

What researchers measure

Primary outcomes

  1. The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

    Time frame: 6 months after the end of radiation therapy

Secondary outcomes

  1. Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters

    Time frame: After radiation: every 6 months for 3 years, then annually for 20 years

06

Study locations

6 of 6 sites recruiting
  • Proton Center of Arkansas
    Little Rock, Arkansas 72205, United States
    • Monica Coleman · Contact · mmcoleman@uams.edu · 501-686-8274
    • Sanjay Maraboyina, MD · Principal investigator
    Recruiting
  • University of Florida Proton Therapy Institute
    Jacksonville, Florida 32206, United States
    • Intake Coordinator · Contact · 877-686-6009
    • Samuel Jean-Baptiste, MD · Principal investigator
    Recruiting
  • Northwestern Medicine Chicago Proton Center
    Warrenville, Illinois 60555, United States
    • Don Smith, MS, CCRC · Contact · donald.smith3@nm.org · 630-933-7820
    • Arpi Thukral, MD · Principal investigator
    Recruiting
  • McLaren Proton Therapy Center
    Flint, Michigan 48532, United States
    Recruiting
  • Mercy David C. Pratt Cancer Center
    St Louis, Missouri 63141, United States
    Recruiting
  • Inova Schar Cancer Institute
    Fairfax, Virginia 22031, United States
    Recruiting
07

References and documents

Publications

  • American Cancer Society. 2007. Ref Type: Electronic Citation
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  • Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23. PubMed 19167731 ↗
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  • Swanson GP, Hussey MA, Tangen CM, Chin J, Messing E, Canby-Hagino E, Forman JD, Thompson IM, Crawford ED; SWOG 8794. Predominant treatment failure in postprostatectomy patients is local: analysis of patterns of treatment failure in SWOG 8794. J Clin Oncol. 2007 Jun 1;25(16):2225-9. doi: 10.1200/JCO.2006.09.6495. PubMed 17538167 ↗
  • King CR, Kapp DS. Radiotherapy after prostatectomy: is the evidence for dose escalation out there? Int J Radiat Oncol Biol Phys. 2008 Jun 1;71(2):346-50. doi: 10.1016/j.ijrobp.2007.10.008. Epub 2008 Jan 30. PubMed 18234451 ↗
  • King CR, Spiotto MT. Improved outcomes with higher doses for salvage radiotherapy after prostatectomy. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):23-7. doi: 10.1016/j.ijrobp.2007.09.047. Epub 2008 Jan 22. PubMed 18207668 ↗
  • Feng M, Hanlon AL, Pisansky TM, Kuban D, Catton CN, Michalski JM, Zelefsky MJ, Kupelian PA, Pollack A, Kestin LL, Valicenti RK, DeWeese TL, Sandler HM. Predictive factors for late genitourinary and gastrointestinal toxicity in patients with prostate cancer treated with adjuvant or salvage radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1417-23. doi: 10.1016/j.ijrobp.2007.01.049. Epub 2007 Apr 6. PubMed 17418972 ↗
  • Vargas C, Fryer A, Mahajan C, Indelicato D, Horne D, Chellini A, McKenzie C, Lawlor P, Henderson R, Li Z, Lin L, Olivier K, Keole S. Dose-volume comparison of proton therapy and intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):744-51. doi: 10.1016/j.ijrobp.2007.07.2335. Epub 2007 Sep 27. PubMed 17904306 ↗
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  • Partin 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 11744442 ↗
  • Spiotto MT, Hancock SL, King CR. Radiotherapy after prostatectomy: improved biochemical relapse-free survival with whole pelvic compared with prostate bed only for high-risk patients. Int J Radiat Oncol Biol Phys. 2007 Sep 1;69(1):54-61. doi: 10.1016/j.ijrobp.2007.02.035. Epub 2007 Apr 24. PubMed 17459606 ↗
  • Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4. PubMed 12126818 ↗
  • Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022. PubMed 15337535 ↗
  • D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821. PubMed 15315996 ↗
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  • Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004. PubMed 12743142 ↗
  • Denham JW, Steigler A, Lamb DS, Joseph D, Mameghan H, Turner S, Matthews J, Franklin I, Atkinson C, North J, Poulsen M, Christie D, Spry NA, Tai KH, Wynne C, Duchesne G, Kovacev O, D'Este C; Trans-Tasman Radiation Oncology Group. Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial. Lancet Oncol. 2005 Nov;6(11):841-50. doi: 10.1016/S1470-2045(05)70348-X. PubMed 16257791 ↗
  • Ghilezan MJ, Jaffray DA, Siewerdsen JH, Van Herk M, Shetty A, Sharpe MB, Zafar Jafri S, Vicini FA, Matter RC, Brabbins DS, Martinez AA. Prostate gland motion assessed with cine-magnetic resonance imaging (cine-MRI). Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):406-17. doi: 10.1016/j.ijrobp.2003.10.017. PubMed 15890582 ↗
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08

Registry details

Key details

Study ID
NCT00969111
Lead sponsor
Proton Collaborative Group
Collaborators
University of Florida Health
Responsible party
Sponsor
First posted
Aug 31, 2009
Start date
Aug 2009
Primary completion
Aug 2031 (estimated)
Completion
Aug 2050 (estimated)
Last update
Jun 17, 2026

Study contacts

Samuel Jean-Baptiste, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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