Prostate CancerPhase 3NCT01839994
Conformal Radiotherapy (CRT) Alone Versus CRT Combined With HDR BT or Stereotactic Body Radiotherapy for Prostate Cancer
A Phase 3 study testing CF-CRT combined with BT or SBRT boost., CF-CRT alone and Hormonal treatment (neoadjuvant androgen deprivation) in people with Prostate Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CF-CRT combined with BT or SBRT boost., CF-CRT alone and Hormonal treatment (neoadjuvant androgen deprivation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2013to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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)
Who cannot join
- 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.
Show all 10Show fewer
- Concurrent uncontrolled medical conditions.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Withdrawal of informed consent.
- -
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, Silesian Voivodeship, 44-100
Katarzyna Behrendt, MD, +4832278818, kbehrendt@io.gliwice.pl
Rafał Suwiński, MD, PhD, +4832278806, rafals@io.gliwice.pl
About this study
Official title: Phase III Clinical Trial on Conventionally Fractionated Conformal Radiotherapy (CF-CRT) Versus CF-CRT Combined With High-dose-rate Brachytherapy or Stereotactic Body Radiotherapy for Intermediate and High-risk Prostate Cancer.
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.
Read the detailed description
Prostate cancer is considered as a disease with relatively slow natural course and good clinical prognosis. Such description, however, does not well refer to intermediate and high-risk cases where long-term rate of biochemical progression remains not satisfactory, and the available treatment modalities entail a considerable morbidity. Over the last decade several competitive therapeutic approaches have evolved in curative treatment for intermediate and high-risk prostate cancer. The use of intensity-modulated radiation therapy (IMRT) made possible to escalate the total dose to the prostate without excessive toxicity.
Based on assumption of low value of low α/β value for adenocarcinoma of prostate, there is a potential of escalating the biological dose to the tumor with higher dose per fraction. High-dose-rate brachytherapy (HDR-BT) is one of the options, with the ability to conform radiation dose to the prostate with sharp dose gradient adjacent to critical organs. An increasing number of studies suggest its usefulness as a boost in intermediate and high risk disease. The randomized trial conducted in UK compared external beam radiotherapy (EBRT) alone with EBRT and HDR brachytherapy as a boost. Combining EBRT with HDR BT - boost resulted in significantly higher relapse-free-survival (RFS) with comparable incidence of severe late toxicity. However, the total dose used in EBRT alone - arm and radiotherapy technique may be considered suboptimal according to current standards.
Stereotactic body radiotherapy (SBRT) may be an interesting alternative to HDR brachytherapy, not requiring implantation of multiple catheters and anesthesia. SBRT boost for advanced localized prostate cancer has the potential to reduce toxicity while escalating the dose. First results of trials combining conventional irradiation with hypofractionated stereotactic boost and institutional pilot results gave promising outcome.
The comparison of these modalities of radiation therapy for prostate cancer will be performed in the current phase III trial study.
- Conditions
- Prostate Cancer
- Being tested
- CF-CRT combined with BT or SBRT boost., CF-CRT alone, Hormonal treatment (neoadjuvant androgen deprivation)
- Keywords
- prostate cancer,, high-dose-rate brachytherapy boost,, stereotactic body radiotherapy boost,, conformal radiotherapy,, randomized trial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 aloneRadiation
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: CF-CRT alone; Drug: Hormonal treatment (neoadjuvant androgen deprivation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from biochemical failure (FFBF)
according to Phoenix definition (rise of PSA level of 2 ng/ml over the absolute nadir)
Measured: 3 years
Secondary outcomes (7)
Freedom from local relapse
Measured: 3 years
Freedom from loco-regional relapse
Measured: 3 years
Freedom from distant metastases
Measured: 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
Measured: 3 months
Time of occurrence, incidence and severity late normal tissue reactions as measured according to CTCAE v4.0 and RTOG/EORTC scoring system
Measured: 3 years
Overall survival
Measured: 5 years
Progression-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafał Suwiński, MD, PhD, Principal investigator, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839994
- Sponsor's protocol ID
- CRT/BT/SBRT-COI-02
- Status last verified
- Apr 2013
- First submitted
- 22 Apr 2013
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16952647Kuban 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.
PubMed 17765406Pieters 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.
PubMed 19748692Martinez 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.
PubMed 12023135Martinez 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.
PubMed 21195875Hoskin 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.
PubMed 22341794Miralbell 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.
PubMed 19910135Quon 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.
PubMed 22079736Jabbari 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.
PubMed 21183287Oermann 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.
PubMed 20815416
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial on Conventionally Fractionated Conformal Radiotherapy (CF-CRT) Versus CF-CRT Combined With High-dose-rate Brachytherapy or Stereotactic Body Radiotherapy for Intermediate and High-risk Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01839994
- Acronym / sponsor ID
- CRT/BT/SBRT-COI-02
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer,, high-dose-rate brachytherapy boost,, stereotactic body radiotherapy boost,, conformal radiotherapy,, randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Apr 2013 (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.
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.
Detailed description
Prostate cancer is considered as a disease with relatively slow natural course and good clinical prognosis. Such description, however, does not well refer to intermediate and high-risk cases where long-term rate of biochemical progression remains not satisfactory, and the available treatment modalities entail a considerable morbidity. Over the last decade several competitive therapeutic approaches have evolved in curative treatment for intermediate and high-risk prostate cancer. The use of intensity-modulated radiation therapy (IMRT) made possible to escalate the total dose to the prostate without excessive toxicity.
Based on assumption of low value of low α/β value for adenocarcinoma of prostate, there is a potential of escalating the biological dose to the tumor with higher dose per fraction. High-dose-rate brachytherapy (HDR-BT) is one of the options, with the ability to conform radiation dose to the prostate with sharp dose gradient adjacent to critical organs. An increasing number of studies suggest its usefulness as a boost in intermediate and high risk disease. The randomized trial conducted in UK compared external beam radiotherapy (EBRT) alone with EBRT and HDR brachytherapy as a boost. Combining EBRT with HDR BT - boost resulted in significantly higher relapse-free-survival (RFS) with comparable incidence of severe late toxicity. However, the total dose used in EBRT alone - arm and radiotherapy technique may be considered suboptimal according to current standards.
Stereotactic body radiotherapy (SBRT) may be an interesting alternative to HDR brachytherapy, not requiring implantation of multiple catheters and anesthesia. SBRT boost for advanced localized prostate cancer has the potential to reduce toxicity while escalating the dose. First results of trials combining conventional irradiation with hypofractionated stereotactic boost and institutional pilot results gave promising outcome.
The comparison of these modalities of radiation therapy for prostate cancer will be performed in the current phase III trial study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF-CRT combined with BT or SBRT boost | Experimental | Radiation: CF-CRT combined with BT or SBRT boost., Drug: Hormonal treatment (neoadjuvant androgen deprivation)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. |
| CF-CRT alone | Active comparator | Radiation: CF-CRT alone, Drug: Hormonal treatment (neoadjuvant androgen deprivation)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%).
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| CF-CRT combined with BT or SBRT boost.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. | Radiation | CF-CRT combined with BT or SBRT boost |
| CF-CRT aloneConventionally 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). | Radiation | CF-CRT alone |
| Hormonal treatment (neoadjuvant androgen deprivation)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. | Drug | CF-CRT alone, CF-CRT combined with BT or SBRT boost |
Primary outcome
Freedom from biochemical failure (FFBF)
Time frame: 3 years
according to Phoenix definition (rise of PSA level of 2 ng/ml over the absolute nadir)
7 secondary outcomes
Freedom from local relapse
Time frame: 3 years
Freedom from loco-regional relapse
Time frame: 3 years
Freedom from distant metastases
Time frame: 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
Time frame: 3 months
Time of occurrence, incidence and severity late normal tissue reactions as measured according to CTCAE v4.0 and RTOG/EORTC scoring system
Time frame: 3 years
Overall survival
Time frame: 5 years
Progression-free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Background: PubMed 16952647Zelefsky 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.
- Background: PubMed 17765406Kuban 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.
- Background: PubMed 19748692Pieters 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.
- Background: PubMed 12023135Martinez 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.
- Background: PubMed 21195875Martinez 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.
- Background: PubMed 22341794Hoskin 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.
- Background: PubMed 19910135Miralbell 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.
- Background: PubMed 22079736Quon 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.
- Background: PubMed 21183287Jabbari 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.
- Background: PubMed 20815416Oermann 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.
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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.
Rafał Suwiński, MD, PhD principal investigator
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CF-CRT combined with BT or SBRT boost., CF-CRT alone and Hormonal treatment (neoadjuvant androgen deprivation) in people with Prostate Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 11 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: status not confirmed, as of the sponsor's last update on 25 Apr 2013. 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 Poland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Behrendt, MD (+4832278818, kbehrendt@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from biochemical failure (FFBF) (time frame: 3 years). 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 NCT01839994, which also lists 10 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 25 Apr 2013.