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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00969111
• Other study ID #: GU010-18
• Secondary ID: UFPTI 0902-PR06
• Status: Recruiting
• Phase: N/A
• Start date: August 2009
• Est. completion date: August 2050

Study information

• Verified date: May 2024
• Source: Proton Collaborative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2050
• Est. primary completion date: August 2031
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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).
• History of hip replacement.
• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
Postop High Risk
• Proton (prostate bed) to 70.2 CGE
Salvage Non-High Risk
• IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Salvage High Risk
• Proton to 66.6 CGE
Post-Op Non High Risk

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida
United States	Northwestern Medicine Chicago Proton Center	Warrenville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Proton Collaborative Group	University of Florida Health

Country where clinical trial is conducted

United States, 

References & Publications (42)

American Cancer Society. 2007. Ref Type: Electronic Citation

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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. — View Citation

Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. doi: 10.1200/JCO.2003.11.023. Erratum In: J Clin Oncol. 2004 Jan 15;22(2):386. — View Citation

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. — View Citation

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. — View Citation

Lefaix JL, Delanian S, Vozenin MC, Leplat JJ, Tricaud Y, Martin M. Striking regression of subcutaneous fibrosis induced by high doses of gamma rays using a combination of pentoxifylline and alpha-tocopherol: an experimental study. Int J Radiat Oncol Biol Phys. 1999 Mar 1;43(4):839-47. doi: 10.1016/s0360-3016(98)00419-2. — View Citation

Litzenberg D, Dawson LA, Sandler H, Sanda MG, McShan DL, Ten Haken RK, Lam KL, Brock KK, Balter JM. Daily prostate targeting using implanted radiopaque markers. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):699-703. doi: 10.1016/s0360-3016(01)02654-2. — View Citation

Litzenberg DW, Balter JM, Hadley SW, Sandler HM, Willoughby TR, Kupelian PA, Levine L. Influence of intrafraction motion on margins for prostate radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):548-53. doi: 10.1016/j.ijrobp.2005.12.033. Epub 2006 Mar 20. — View Citation

Padhani AR, Khoo VS, Suckling J, Husband JE, Leach MO, Dearnaley DP. Evaluating the effect of rectal distension and rectal movement on prostate gland position using cine MRI. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):525-33. doi: 10.1016/s0360-3016(99)00040-1. — View Citation

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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. — View Citation

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.		6 months after the end of radiation therapy
Secondary	Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters		After radiation: every 6 months for 3 years, then annually for 20 years