Conformal Radiotherapy (CRT) Alone Versus CRT Combined With HDR BT or Stereotactic Body Radiotherapy for Prostate Cancer

NCT01839994 | Unknown Phase 3

• 1 other identifier: CRT/BT/SBRT-COI-02
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the outcomes of conventionally fractionated conformal radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic body radiotherapy for intermediate or high-risk prostate cancer patients.

Conditions

Prostate Cancer

Keywords

prostate cancer,; high-dose-rate brachytherapy boost,; stereotactic body radiotherapy boost,; conformal radiotherapy,; randomized trial

Outcome Measures

Primary Outcomes (1)

• Freedom from biochemical failure (FFBF)

  according to Phoenix definition (rise of PSA level of 2 ng/ml over the absolute nadir)

  3 years

Secondary Outcomes (7)

• Freedom from local relapse

  3 years

• Freedom from loco-regional relapse

  3 years

• Freedom from distant metastases

  3 years

• Time of occurrence, incidence and severity of acute normal tissue reactions as measured according to CTCAE v4.0 and RTOG/EORTC scoring system

  3 months

• Time of occurrence, incidence and severity late normal tissue reactions as measured according to CTCAE v4.0 and RTOG/EORTC scoring system

  3 years

Other Outcomes (1)

• Identification of molecular and biochemical predictors of response to external beam radiotherapy and brachytherapy or SBRT boost as compared to external beam radiotherapy alone

  3 years

Study Arms (2)

CF-CRT combined with BT or SBRT boost

EXPERIMENTAL

Conventionally fractionated CRT (IMRT or Rapid Arc) to the TD of 50 Gy, 2.0 Gy d fx, 5 days a week over the period of 5 weeks AND two 10 Gy fractions of real- time HDR brachytherapy OR CRT combined with two stereotactic body radiotherapy boosts of 10 Gy per fraction delivered with dynamic SBRT technique (IMRT or Rapid Arc). The choice between two ways of delivering radiation dose to the boost volume will be based solely on clinical criteria, decision made by interdisciplinary team, according to the institutional protocol (in non-randomized fashion). Hormonal treatment: three months of neoadjuvant androgen deprivation (MAB -maximal androgen blockade) in all patients. Long-term (3 years) of adjuvant hormonotherapy (LHRH agonists only) in high risk patients.

Radiation: CF-CRT combined with BT or SBRT boost.; Drug: Hormonal treatment (neoadjuvant androgen deprivation)

CF-CRT alone

ACTIVE COMPARATOR

Conventionally fractionated external beam conformal radiotherapy (IMRT or Rapid Arc) to the prostate and seminal vesicles (intermediate risk group) or to the prostate, SV and pelvic lymph nodes (high risk group) to the total dose of 50 Gy in 2.0 Gy per fraction, 5 days a week over the period of 5 weeks, followed by a boost to the prostate (26 or 28 Gy in 2.0 Gy per fraction 5 days a week over the period of 2.5 weeks) to the total dose of 76 or 78 Gy (intermediate or high risk group of patients, respectively). Hormonal treatment: three months of neoadjuvant androgen deprivation (MAB -maximal androgen blockade) in all patients. Long-term (3 years) of adjuvant hormonotherapy (LHRH agonists only) in high risk patients.

Radiation: CF-CRT alone; Drug: Hormonal treatment (neoadjuvant androgen deprivation)

Interventions

CF-CRT combined with BT or SBRT boost. RADIATION

CF-CRT to the prostate and SV (IM risk group) or to the prostate, SV and LN (high risk group) to the TD of 50 Gy, 2.0 Gy d fx, 5 days a week over the period of 5 weeks AND A. Two 10 Gy fractions of HDR BT 1-7 d. before external beam radiotherapy and one 1-7 d. after external beam radiotherapy OR B. Two stereotactic body radiotherapy (SBRT) fractions of 10 Gy to the prostate (CTV boost) delivered with dynamic SBRT technique (IMRT or Rapid Arc). First and second fraction of SBRT boost is scheduled 1-7 d. before and 1-7 d. after the start of conventionally fractionated radiotherapy, respectively.

CF-CRT combined with BT or SBRT boost

CF-CRT alone RADIATION

Conventionally fractionated EB-CRT (IMRT or Rapid Arc) to the TD of 50 Gy, followed by a boost to the prostate (26 or 28 Gy in 2.0 Gy per fraction 5 days a week over the period of 2.5 weeks) to the total dose of 76 or 78 Gy (intermediate or high risk group of patients, respectively).of 50 Gy in 2.0 Gy per fraction, 5 days a week over the period of 5 weeks, followed by a boost to the prostate (26 or 28 Gy in 2.0 Gy per fraction 5 days a week over the period of 2.5 weeks) to the total dose of 76 or 78 Gy (intermediate or high risk group of patients, respectively).

CF-CRT alone

Hormonal treatment (neoadjuvant androgen deprivation) DRUG

Hormonal treatment: three months of neoadjuvant androgen deprivation (MAB -maximal androgen blockade) in all patients. Long-term (3 years) of adjuvant hormonotherapy (LHRH agonists only) in high risk patients.

CF-CRT alone; CF-CRT combined with BT or SBRT boost

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven adenocarcinoma of the prostate
• Clinical stage T1-T3a (Intermediate or high risk features according to NCCN criteria)
• No evidence of nodal or distant spread as determined by chest X-ray, bone scan and abdominal ultrasound or CT-scan or other investigations such as Positron Emission Tomography \[PET\] scan if required
• No evidence of bulky spread beyond the capsule of the prostate, no seminal vesicle involvement assessed by TRUS or MRI of pelvis.
• Good performance status (ZUBROD \<2, Karnofsky index \>=80%).
• No contradictions for spinal anesthesia.
• No contradictions for hormonal treatment (androgen deprivation).
• Adequate bone marrow, renal and liver function.
• Life expectancy in excess of 5 years.
• No prior malignancy, except basal or squamous cell skin cancer.
• Informed consent for participation in the study (confirmed by the signature together with the standard medical consent form for radiotherapy within the pelvis)

You may not qualify if:

• Different histology than adenocarcinoma.
• Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin.
• Locally advanced disease: bulky T3a and/or T3b.
• Presence of metastatic disease (nodal and/or distant).
• PSA \>100ng/ml
• Any previous therapy other than hormonal treatment.
• Concurrent uncontrolled medical conditions.
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
• Withdrawal of informed consent.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch

Gliwice, Silesian Voivodeship, 44-100, Poland

Location

Related Publications (10)

• Zelefsky MJ, Chan H, Hunt M, Yamada Y, Shippy AM, Amols H. Long-term outcome of high dose intensity modulated radiation therapy for patients with clinically localized prostate cancer. J Urol. 2006 Oct;176(4 Pt 1):1415-9. doi: 10.1016/j.juro.2006.06.002.

  PMID: 16952647 BACKGROUND

• Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.

  PMID: 17765406 BACKGROUND

• Pieters BR, de Back DZ, Koning CC, Zwinderman AH. Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. Radiother Oncol. 2009 Nov;93(2):168-73. doi: 10.1016/j.radonc.2009.08.033. Epub 2009 Sep 11.

  PMID: 19748692 BACKGROUND

• Martinez AA, Gustafson G, Gonzalez J, Armour E, Mitchell C, Edmundson G, Spencer W, Stromberg J, Huang R, Vicini F. Dose escalation using conformal high-dose-rate brachytherapy improves outcome in unfavorable prostate cancer. Int J Radiat Oncol Biol Phys. 2002 Jun 1;53(2):316-27. doi: 10.1016/s0360-3016(02)02733-5.

  PMID: 12023135 BACKGROUND

• Martinez AA, Gonzalez J, Ye H, Ghilezan M, Shetty S, Kernen K, Gustafson G, Krauss D, Vicini F, Kestin L. Dose escalation improves cancer-related events at 10 years for intermediate- and high-risk prostate cancer patients treated with hypofractionated high-dose-rate boost and external beam radiotherapy. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):363-70. doi: 10.1016/j.ijrobp.2009.10.035.

  PMID: 21195875 BACKGROUND

• Hoskin PJ, Rojas AM, Bownes PJ, Lowe GJ, Ostler PJ, Bryant L. Randomised trial of external beam radiotherapy alone or combined with high-dose-rate brachytherapy boost for localised prostate cancer. Radiother Oncol. 2012 May;103(2):217-22. doi: 10.1016/j.radonc.2012.01.007. Epub 2012 Feb 16.

  PMID: 22341794 BACKGROUND

• Miralbell R, Molla M, Rouzaud M, Hidalgo A, Toscas JI, Lozano J, Sanz S, Ares C, Jorcano S, Linero D, Escude L. Hypofractionated boost to the dominant tumor region with intensity modulated stereotactic radiotherapy for prostate cancer: a sequential dose escalation pilot study. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):50-7. doi: 10.1016/j.ijrobp.2009.07.1689. Epub 2009 Nov 10.

  PMID: 19910135 BACKGROUND

• Quon H, Cheung PC, Loblaw DA, Morton G, Pang G, Szumacher E, Danjoux C, Choo R, Kiss A, Mamedov A, Deabreu A. Quality of life after hypofractionated concomitant intensity-modulated radiotherapy boost for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2012 Jun 1;83(2):617-23. doi: 10.1016/j.ijrobp.2011.07.005. Epub 2011 Nov 11.

  PMID: 22079736 BACKGROUND

• Jabbari S, Weinberg VK, Kaprealian T, Hsu IC, Ma L, Chuang C, Descovich M, Shiao S, Shinohara K, Roach M 3rd, Gottschalk AR. Stereotactic body radiotherapy as monotherapy or post-external beam radiotherapy boost for prostate cancer: technique, early toxicity, and PSA response. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):228-34. doi: 10.1016/j.ijrobp.2010.10.026. Epub 2010 Dec 22.

  PMID: 21183287 BACKGROUND

• Oermann EK, Slack RS, Hanscom HN, Lei S, Suy S, Park HU, Kim JS, Sherer BA, Collins BT, Satinsky AN, Harter KW, Batipps GP, Constantinople NL, Dejter SW, Maxted WC, Regan JB, Pahira JJ, McGeagh KG, Jha RC, Dawson NA, Dritschilo A, Lynch JH, Collins SP. A pilot study of intensity modulated radiation therapy with hypofractionated stereotactic body radiation therapy (SBRT) boost in the treatment of intermediate- to high-risk prostate cancer. Technol Cancer Res Treat. 2010 Oct;9(5):453-62. doi: 10.1177/153303461000900503.

  PMID: 20815416 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Rafał Suwiński, MD, PhD

  Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Behrendt, MD

CONTACT

+4832278818; kbehrendt@io.gliwice.pl

Rafał Suwiński, MD, PhD

CONTACT

+48322788806; rafals@io.gliwice.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 25, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

PL (1)