Prostate CancerRCMIGINCT03254420

Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins.

A study testing Calypso beacon implant and moderate hypofractionation Radiotherapy in people with Prostate Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The Calypso® System (Varian Medical Systems, Inc., Palo Alto, CA) is a recent technology using electromagnetic transponders implanted within the prostate. It is a real-time target tracking system that takes into account both inter- and intrafractional target motion. 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?: Calypso beacon implant and moderate hypofractionation Radiotherapy
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteFrance
Study dates: 30 Aug 2016to Dec 2028
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 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Localized prostate cancer, histologically proven.
No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral lymph node dissection is not mandatory if lymph node involvement risk is low according to the Partin tables).
Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2 and Gleason < 8 and PSA < 20 ng/ml) (appendix 3).
No grade > 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03 scale.
Performance status ECOG ≤ 1.
No hip prosthesis or metallic vascular graft near the prostate.

Show all 14Show fewer

No endopenian stent.
No pace maker, implanted defibrillator or neurostimulator.
No allergy to local anesthetics.
No irreversible anticoagulation or antiplatelet treatment for the implantation period.
Pelvic and abdominal anatomy compatible with the use of the Calypso® system (predictive detector to fiducials distance less than 19 cm, evaluated on planning CT-scan) (distance from skin surface to prostate center less than 17 cm).
Patient aged ≥ 18 and less than 80 years old.
Dated and signed written informed consent available.
Patients must be affiliated to a French Social Security System.

Who cannot join

Indication of pelvic nodes irradiation.
Prior pelvic irradiation.
Biopsy-proven seminal vesicle invasion.
Prior bilateral orchiectomy.
Prior radical prostatectomy.
Other malignancy except adequately-treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease-free for at least 5 years.

Show all 10Show fewer

Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Other uncontrolled systemic disease (cardiovascular, renal, liver, pulmonary embolism, etc.).
Known VIH positive patients (no specific test needed).
Known homozygote ATM Mutation (Ataxia telengiectasia).

Trial locations and contacts

1 site in 1 country.

France1 site

Institut regional du Cancer - Val d Aurelle
Montpellier, 34298

Other trials in France

About this study

Official title: Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)

The aim of this study is to assess pelvic late toxicity rate after intensity-modulated radiotherapy (IMRT) when using the Calypso® System with a reduction of treatment margins. In this randomized study, patients will receive IGRT treatment using the Calypso system or a conventional IGRT treatment.

Read the detailed description

Prostate cancer is the most frequent cancer in men. Radiotherapy is one of the reference treatments for localized prostate cancer. Prostate was initially thought to be a non-moving target, but the newest reports have raised the contrary as evidence. Image-guided radiotherapy (IGRT) is a current standard treatment for localized prostate cancer which enables to take into account interfractional prostate motion before treatment.

As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ motion, margin reduction can reasonably be considered in case of target motion management improvement.

To date, no prospective randomized clinical data is available using this technique for the treatment of low- or intermediate-risk prostate cancer patients with modern standard fractionation radiotherapy and image guidance.

Conditions: Prostate Cancer
Being tested: Calypso beacon implant, moderate hypofractionation Radiotherapy
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calypso beacon implantDevice
Calypso beacon implant before radiotherapy
moderate hypofractionation RadiotherapyRadiation
moderate hypofractionation Radiotherapy

Study groups in NCT03254420
Study group	Role	What they receive
Image-guided radiation therapy (IGRT) with standard margins	Active comparator	moderate hypofractionation during 4 weeks Receives: Radiation: moderate hypofractionation Radiotherapy
Calypso tracking system with margin reduction	Experimental	moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Receives: Device: Calypso beacon implant; Radiation: moderate hypofractionation Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Grade > 2 Late Pelvic Toxicities
assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period
Measured: between 3 months and 2 years after radiation period

Secondary outcomes (3)

Biological Relapse-free Survival
evaluate at 5 years with PSA dosage
Measured: at 5 years after the radiotherapy
Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)
evaluate et 5 years after the treatment with radiological exam
Measured: at 5 years after the radiotherapy
Overall Survival
number of death from baseline to 5 years after the treatment
Measured: from the baseline to 5 years after the radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 2016Dec 2028

First posted18 Aug 2017
Study start30 Aug 2016
Primary completion15 Sep 2022
Study completionDec 2028 (estimated)

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 (43)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 Institut du Cancer de Montpellier - Val d'AurelleThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254420
Sponsor's protocol ID: ICM-URC2015/33
Acronym: RCMIGI
Status last verified: Jun 2026
First submitted: 16 Aug 2017
Last updated: 23 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Publications

Jereczek-Fossa BA, Orecchia R. Evidence-based radiation oncology: definitive, adjuvant and salvage radiotherapy for non-metastatic prostate cancer. Radiother Oncol. 2007 Aug;84(2):197-215. doi: 10.1016/j.radonc.2007.04.013. Epub 2007 May 29.
PubMed 17532494
Zaorsky NG, Harrison AS, Trabulsi EJ, Gomella LG, Showalter TN, Hurwitz MD, Dicker AP, Den RB. Evolution of advanced technologies in prostate cancer radiotherapy. Nat Rev Urol. 2013 Oct;10(10):565-79. doi: 10.1038/nrurol.2013.185. Epub 2013 Sep 10.
PubMed 24018567
Budaus L, Bolla M, Bossi A, Cozzarini C, Crook J, Widmark A, Wiegel T. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur Urol. 2012 Jan;61(1):112-27. doi: 10.1016/j.eururo.2011.09.027. Epub 2011 Oct 6.
PubMed 22001105
Ohri N, Dicker AP, Showalter TN. Late toxicity rates following definitive radiotherapy for prostate cancer. Can J Urol. 2012 Aug;19(4):6373-80.
PubMed 22892261
Pardo Y, Guedea F, Aguilo F, Fernandez P, Macias V, Marino A, Hervas A, Herruzo I, Ortiz MJ, Ponce de Leon J, Craven-Bratle J, Suarez JF, Boladeras A, Pont A, Ayala A, Sancho G, Martinez E, Alonso J, Ferrer M. Quality-of-life impact of primary treatments for localized prostate cancer in patients without hormonal treatment. J Clin Oncol. 2010 Nov 1;28(31):4687-96. doi: 10.1200/JCO.2009.25.3245. Epub 2010 Oct 4.
PubMed 20921463
de Crevoisier R, Fiorino C, Dubray B. [Dosimetric factors predictive of late toxicity in prostate cancer radiotherapy]. Cancer Radiother. 2010 Oct;14(6-7):460-8. doi: 10.1016/j.canrad.2010.07.225. Epub 2010 Aug 24. French.
PubMed 20797890
Valdagni R, Rancati T, Fiorino C. Predictive models of toxicity with external radiotherapy for prostate cancer: clinical issues. Cancer. 2009 Jul 1;115(13 Suppl):3141-9. doi: 10.1002/cncr.24356.
PubMed 19544543
Yu JB. Hypofractionated Radiotherapy for Prostate Cancer: Further Evidence to Tip the Scales. J Clin Oncol. 2017 Jun 10;35(17):1867-1869. doi: 10.1200/JCO.2017.72.7016. Epub 2017 Mar 29. No abstract available.
PubMed 28355114
Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
PubMed 27339115
Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.
PubMed 27044935
Incrocci L, Wortel RC, Alemayehu WG, Aluwini S, Schimmel E, Krol S, van der Toorn PP, Jager H, Heemsbergen W, Heijmen B, Pos F. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1061-1069. doi: 10.1016/S1470-2045(16)30070-5. Epub 2016 Jun 20.
PubMed 27339116
Arcangeli G, Saracino B, Arcangeli S, Gomellini S, Petrongari MG, Sanguineti G, Strigari L. Moderate Hypofractionation in High-Risk, Organ-Confined Prostate Cancer: Final Results of a Phase III Randomized Trial. J Clin Oncol. 2017 Jun 10;35(17):1891-1897. doi: 10.1200/JCO.2016.70.4189. Epub 2017 Mar 29.
PubMed 28355113
Catton CN, Lukka H, Gu CS, Martin JM, Supiot S, Chung PWM, Bauman GS, Bahary JP, Ahmed S, Cheung P, Tai KH, Wu JS, Parliament MB, Tsakiridis T, Corbett TB, Tang C, Dayes IS, Warde P, Craig TK, Julian JA, Levine MN. Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer. J Clin Oncol. 2017 Jun 10;35(17):1884-1890. doi: 10.1200/JCO.2016.71.7397. Epub 2017 Mar 15.
PubMed 28296582
Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.
PubMed 33172724
Rodin D, Tawk B, Mohamad O, Grover S, Moraes FY, Yap ML, Zubizarreta E, Lievens Y. Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey. Radiother Oncol. 2021 Apr;157:32-39. doi: 10.1016/j.radonc.2021.01.003. Epub 2021 Jan 14.
PubMed 33453312

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase II Study Evaluating Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (RCMIGI)
ClinicalTrials.gov ID: NCT03254420
Acronym / sponsor ID: RCMIGI / ICM-URC2015/33
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 74 participants (actual)
Lead sponsor: Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
Study start: 30 Aug 2016 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: Dec 2028 (estimated)
First posted: 18 Aug 2017 (actual)
Results: Posted 6 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

As Planned Target Volume (PTV) margins integrate set-up margins and the management of organ motion, margin reduction can reasonably be considered in case of target motion management improvement.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Image-guided radiation therapy (IGRT) with standard margins	Active comparator	Radiation: moderate hypofractionation Radiotherapymoderate hypofractionation during 4 weeks
Calypso tracking system with margin reduction	Experimental	Device: Calypso beacon implant, Radiation: moderate hypofractionation Radiotherapymoderate hypofractionation during 4 weeks after calypso beacon implant 10 days before

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Localized prostate cancer, histologically proven.
No evidence of metastases (M0). No evidence of lymph nodes involvement (N0) (bilateral lymph node dissection is not mandatory if lymph node involvement risk is low according to the Partin tables).
Low-risk or intermediate clinical stage according to the D'Amico classification (T1-T2 and Gleason < 8 and PSA < 20 ng/ml) (appendix 3).
No grade > 2 urinary or rectal clinical sign or symptom according to the CTCAE V4.03 scale.
Performance status ECOG ≤ 1.

Key exclusion criteria (10 listed)

Indication of pelvic nodes irradiation.
Prior pelvic irradiation.
Biopsy-proven seminal vesicle invasion.
Prior bilateral orchiectomy.
Prior radical prostatectomy.

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
Calypso beacon implantCalypso beacon implant before radiotherapy	Device	Calypso tracking system with margin reduction
moderate hypofractionation Radiotherapymoderate hypofractionation Radiotherapy	Radiation	Calypso tracking system with margin reduction, Image-guided radiation therapy (IGRT) with standard margins

Primary outcome

Assessment of Grade > 2 Late Pelvic Toxicities
Time frame: between 3 months and 2 years after radiation period
assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period

3 secondary outcomes

Biological Relapse-free Survival
Time frame: at 5 years after the radiotherapy
Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)
Time frame: at 5 years after the radiotherapy
Overall Survival
Time frame: from the baseline to 5 years after the radiotherapy

Results and safety

Results posted to the registry on 6 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Image-guided Radiation Therapy (IGRT) With Standard Margins	29	26
Calypso Tracking System With Margin Reduction	45	44

Primary outcome: Assessment of Grade > 2 Late Pelvic Toxicities

Time frame: between 3 months and 2 years after radiation period. Count of participants. Unit: Participants

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n = 26	Calypso Tracking System With Margin Reduction n = 44
failure	5	5
success	21	39

Population analysed: failure : presence of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period success : absence of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: adverse event data were collected from the baseline to 5 years after the radiotherapy. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Image-guided Radiation Therapy (IGRT) With Standard Margins	2 of 26 (7.7%)	26 of 26 (100%)	0 of 26
Calypso Tracking System With Margin Reduction	9 of 44 (20.5%)	44 of 44 (100%)	2 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17532494Jereczek-Fossa BA, Orecchia R. Evidence-based radiation oncology: definitive, adjuvant and salvage radiotherapy for non-metastatic prostate cancer. Radiother Oncol. 2007 Aug;84(2):197-215. doi: 10.1016/j.radonc.2007.04.013. Epub 2007 May 29.
Background: PubMed 24018567Zaorsky NG, Harrison AS, Trabulsi EJ, Gomella LG, Showalter TN, Hurwitz MD, Dicker AP, Den RB. Evolution of advanced technologies in prostate cancer radiotherapy. Nat Rev Urol. 2013 Oct;10(10):565-79. doi: 10.1038/nrurol.2013.185. Epub 2013 Sep 10.
Background: PubMed 22001105Budaus L, Bolla M, Bossi A, Cozzarini C, Crook J, Widmark A, Wiegel T. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur Urol. 2012 Jan;61(1):112-27. doi: 10.1016/j.eururo.2011.09.027. Epub 2011 Oct 6.
Background: PubMed 22892261Ohri N, Dicker AP, Showalter TN. Late toxicity rates following definitive radiotherapy for prostate cancer. Can J Urol. 2012 Aug;19(4):6373-80.
Background: PubMed 20921463Pardo Y, Guedea F, Aguilo F, Fernandez P, Macias V, Marino A, Hervas A, Herruzo I, Ortiz MJ, Ponce de Leon J, Craven-Bratle J, Suarez JF, Boladeras A, Pont A, Ayala A, Sancho G, Martinez E, Alonso J, Ferrer M. Quality-of-life impact of primary treatments for localized prostate cancer in patients without hormonal treatment. J Clin Oncol. 2010 Nov 1;28(31):4687-96. doi: 10.1200/JCO.2009.25.3245. Epub 2010 Oct 4.
Background: PubMed 20797890de Crevoisier R, Fiorino C, Dubray B. [Dosimetric factors predictive of late toxicity in prostate cancer radiotherapy]. Cancer Radiother. 2010 Oct;14(6-7):460-8. doi: 10.1016/j.canrad.2010.07.225. Epub 2010 Aug 24. French.
Background: PubMed 19544543Valdagni R, Rancati T, Fiorino C. Predictive models of toxicity with external radiotherapy for prostate cancer: clinical issues. Cancer. 2009 Jul 1;115(13 Suppl):3141-9. doi: 10.1002/cncr.24356.
Background: PubMed 28355114Yu JB. Hypofractionated Radiotherapy for Prostate Cancer: Further Evidence to Tip the Scales. J Clin Oncol. 2017 Jun 10;35(17):1867-1869. doi: 10.1200/JCO.2017.72.7016. Epub 2017 Mar 29. No abstract available.
Background: PubMed 27339115Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
Background: PubMed 27044935Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4.
Background: PubMed 27339116Incrocci L, Wortel RC, Alemayehu WG, Aluwini S, Schimmel E, Krol S, van der Toorn PP, Jager H, Heemsbergen W, Heijmen B, Pos F. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1061-1069. doi: 10.1016/S1470-2045(16)30070-5. Epub 2016 Jun 20.
Background: PubMed 28355113Arcangeli G, Saracino B, Arcangeli S, Gomellini S, Petrongari MG, Sanguineti G, Strigari L. Moderate Hypofractionation in High-Risk, Organ-Confined Prostate Cancer: Final Results of a Phase III Randomized Trial. J Clin Oncol. 2017 Jun 10;35(17):1891-1897. doi: 10.1200/JCO.2016.70.4189. Epub 2017 Mar 29.
Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

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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.

Riou Olivier study chair

Institut régional du Cancer de Montpellier

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Calypso beacon implant and moderate hypofractionation Radiotherapy in people with Prostate Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

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 14 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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 France. 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 6 Feb 2025). 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?

Assessment of Grade > 2 Late Pelvic Toxicities (time frame: between 3 months and 2 years after radiation period). 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 NCT03254420, which also lists 43 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 23 Jun 2026.