Prostate CancerPhase 3NCT01272050
Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery
A Phase 3 study testing radiation therapy in people with Prostate Cancer, run by Swiss Cancer Institute at 28 sites in 3 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with relapsed prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 6 Jan 2011to 31 May 2024
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must give written informed consent before randomization.
- Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy at least 12 weeks before randomization. Tumor stage pT2a-3b, R0-1, pN0 or cN0 according to the UICC TNM 2009 (see Appendix 1), Gleason score available.
- PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises. The first value must be measured earliest 4 weeks after radical prostatectomy.
- PSA at randomization ≤ 2 ng/mL.
- WHO performance status 0-1 at randomization.
- Age at randomization between 18 and 75 years.
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- Baseline QoL questionnaire (QLQ) has been completed.
- Patient agrees not to father a child during salvage RT and during 6 months thereafter.
- Patient compliance and geographic proximity allow proper staging and follow-up.
- The responsible pathologist has agreed to provide sample material for central pathological review (see Section 16) and tissue banking (only if patient gave informed consent) within the specified timelines.
Who cannot join
- Persistent PSA 4-20 weeks after radical prostatectomy > 0.4 ng/mL
- Palpable prostatic fossa mass suggestive of recurrence, unless an ultrasound guided biopsy is non-malignant.
- Pre-salvage RT pelvic lymph node enlargement > 1 cm in short axis diameter of the abdomen and pelvis (cN1), unless the enlarged lymph node is sampled and negative, and/or evidence of macroscopic local recurrence or metastatic disease on pre-salvage RT MRI (magnetic resonance imaging; with i.v. contrast) or multislice computed tomography (CT; with i.v. and oral contrast) of the abdomen and pelvis assessed within 16 weeks prior to randomization.
- Presence or history of bone metastases. Bone scan must be performed in case of clinical suspicion (e.g. bone pain).
- Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival for a minimum of 5 years.
- Hormonal treatment or bilateral orchiectomy prior to or following prostatectomy.
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- Bilateral hip prosthesis.
- Prior pelvic radiotherapy.
- The use of products known to affect PSA levels within 4 weeks prior to start of trial treatment (e.g. PC Calm, PC Plus, PC SPES, finasteride, fluconazole).
- Severe or active co-morbidity likely to impact on the advisability of dose intensified salvage RT.
- Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent or filling out QoL questionnaires.
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry.
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
Switzerland14 sites
Kantonsspital Aarau
Aarau, 5001
Universitaetsspital-Basel
Basel, CH-4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500
Inselspital Bern
Bern, 3010
Radio-Onkologiezentrum Biel-Seeland-Berner Jura AG
Biel, 2503
Kantonsspital Graubuenden
Chur, 7000
Kantonsspital Luzern
Lucerne, 6000
Kantonsspital Muensterlingen
Münsterlingen, 8596
Kantonsspital - St. Gallen
Sankt Gallen, 9007
Hopital de Sion
Sion, 1951
Radio-Onkologie Berner Oberland AG
Thun, 3600
Klinik Hirslanden
Zurich, 8032
City Hospital Triemli
Zurich, 8063
UniversitaetsSpital Zuerich
Zurich, 8091
Germany11 sites
Universitaetsklinikum Aachen, Klinik für Strahlentherapie
Aachen, 52074
Charite University Hospital - Campus Virchow Klinikum
Berlin, 13353
University Hospital and Medical Faculty Technical University of Dresden
Dresden, D-01307
Universitaetsklinikum Essen, Klinik für Strahlentherapie
Essen, 45147
Universitätsklinikum Saarland
Homburg, 66421
Klinikum der LMU Muenchen
Munich, D-81377
Technische Universitaet Muenchen
Munich, D-81675
Klinikum der Universitaet Regensburg
Regensburg, 93051
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
Rostock, 18059
Universitaet Tuebingen
Tübingen, 72076
Klinik fuer Strahlentherapie Universitaet Wuerzburg
Würzburg, 97080
Belgium3 sites
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, 2020
Ghent University Hospital
Ghent, 9000
St. Lukas Hospital Ghent
Ghent, 9000
About this study
Official title: Dose Intensified Salvage Radiotherapy in Biochemically Relapsed Prostate Cancer Without Macroscopic Disease. A Randomized Phase III Trial.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with relapsed prostate cancer.
PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy and comparing two radiation therapy regimens in treating patients with relapsed prostate cancer after surgery.
Read the detailed description
OBJECTIVES:
- To determine the tumor control in patients with biochemically relapsed prostate cancer without macroscopic disease treated with dose-intensive salvage radiotherapy.
- To determine the toxicity in these patients.
- To determine the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), pathological tumor classification (pT3b vs others), lymphadenectomy performed (yes [pN0] vs no [cN0]), persistent PSA after prostatectomy (detectable [≥ 0.1 ng/mL] vs undetectable [< 0.1 ng/mL]), PSA at randomization (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center, and radiotherapy technique (3-dimensional conformal radiation therapy [3D-CRT] vs intensity-modulated radiation therapy [IMRT]/rotational techniques). Patient are randomized to 1 of 2 treatment arms.
- Arm A: Beginning at least 12 weeks after surgery, patients undergo radiotherapy* once a day, 5 days a week, for 6.4 weeks for a total dose of 64 Gy (in 32 fractions of 2 Gy over 6.4 weeks).
- Arm B: Patients undergo radiotherapy* once a day, 5 days a week, for 7 weeks for a total dose of 70 Gy (in 35 fractions of 2 Gy over 7 weeks).
NOTE: *3-dimensional conformal radiation therapy, rotational techniques such as Tomotherapy®, Rapidarc®, or intensity-modulated arc technique and volumetric-modulated arc therapy are all eligible.
Patients complete quality-of-life questionnaires at baseline and at 3, 12, 24, 36, 48, and 60 months after completing study therapy.
After completion of study treatment, patients are followed every 6 months for 3 years and then every 12 months for up to 10 years.
- Conditions
- Prostate Cancer
- Being tested
- radiation therapy
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
RT in the standard arm A will be administered to a total dose of 64 Gy in 32 fractions of 2 Gy over 6.4 weeks. RT in the experimental arm B will be administered to a total dose of 70 Gy in 35 fractions of 2 Gy over 7 weeks.
Megavoltage equipments with nominal photon energies ≥ 6 MV are required. Rotational techniques such as Tomotherapy®, Rapidarc®, intensity-modulated arc technique (IMAT) and volumetric-modulated arc therapy (VMAT) will also be eligible. The patient will be treated in an isocentric setting and all fields will be applied for 5 days per week for the total RT duration.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 64 Gy - Radiation Therapy | Active comparator | Arm A: 64 Gy (32 x 2 Gy) without hormonal treatment Receives: Radiation: radiation therapy |
| Arm B: 70 Gy - Radiation Therapy | Active comparator | Arm B: 70 Gy (35 x 2 Gy) without hormonal treatment Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from biochemical progression
Measured: from the day of trial randomization to the day of either first recorded biochemical progression, clinical progression or death due to clinical progression up to 10 years.
Secondary outcomes (5)
Clinical progression-free survival
Measured: from the day of randomization to the day of the first record of either local or regional recurrence, distant recurrence, start of hormonal treatment, or death due to any cause up to 10 years.
Time to hormonal treatment
Measured: time from trial randomization to start of hormonal treatment up to 10 years.
Prostate cancer-specific survival
Measured: time from trial randomization to the date of death due to prostate cancer up to 10 years.
Overall survival
Measured: time from trial randomization to the date of death from any cause up to 10 years.
Acute and late gastrointestinal and genitourinary toxicity according to CTCAE v 4.0
Measured: occurring during treatment and up to 3 months after completion of treatment. Late toxicity is defined as occurring later than 3 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study start6 Jan 2011
- Primary completion3 Jul 2020
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Factorial
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pirus Ghadjar, MD, Study chair, Charite University, Berlin, GermanyDaniel M. Aebersold, Prof., Study chair, Bern University HospitalGeorge N. Thalmann, Prof., Study chair, Bern University HospitalDaniel Zwahlen, PD Dr., Study chair, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272050
- Sponsor's protocol ID
- SAKK 09/10
- Other IDs
- SWS-SAKK-09/10, EU-21088, CDR0000691926
- Status last verified
- Aug 2024
- First submitted
- 6 Jan 2011
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ghadjar P, Hayoz S, Zwahlen DR, Holscher T, Arnold W, Polat B, Hildebrandt G, Hoffmann E, Plasswilm L, Papachristofilou A, Schar C, Sumila M, Zaugg K, Guckenberger M, Ost P, Reuter C, Bosetti DG, Khanfir K, Riesterer O, Beck M, Thalmann GN, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: Long-term Data from the SAKK 09/10 Randomised Phase 3 Trial. Eur Urol. 2026 Mar;89(3):199-203. doi: 10.1016/j.eururo.2025.12.020. Epub 2026 Jan 5.
PubMed 41494929Zwahlen DR, Schroder C, Holer L, Bernhard J, Holscher T, Arnold W, Polat B, Hildebrandt G, Muller AC, Martin Putora P, Papachristofilou A, Schar C, Hayoz S, Sumila M, Zaugg K, Guckenberger M, Ost P, Giovanni Bosetti D, Reuter C, Gomez S, Khanfir K, Beck M, Thalmann GN, Aebersold DM, Ghadjar P. Erectile function preservation after salvage radiation therapy for biochemically recurrent prostate cancer after prostatectomy: Five-year results of the SAKK 09/10 randomized phase 3 trial. Clin Transl Radiat Oncol. 2024 Apr 25;47:100786. doi: 10.1016/j.ctro.2024.100786. eCollection 2024 Jul.
PubMed 38706726Beck M, Sassowsky M, Schar S, Mathier E, Halter M, Zwahlen DR, Holscher T, Arnold W, Polat B, Hildebrandt G, Muller AC, Putora PM, Papachristofilou A, Hayoz S, Schar C, Li Q, Sumila M, Zaugg K, Guckenberger M, Ost P, Bosetti DG, Reuter C, Gomez S, Khanfir K, Aebersold DM, Ghadjar P, Pra AD. Adherence to Contouring and Treatment Planning Requirements Within a Multicentric Trial: Results of the Quality Assurance of the SAKK 09/10 trial. Int J Radiat Oncol Biol Phys. 2022 May 1;113(1):80-91. doi: 10.1016/j.ijrobp.2021.12.174. Epub 2022 Jan 3.
PubMed 34990777Ghadjar P, Hayoz S, Bernhard J, Zwahlen DR, Holscher T, Gut P, Polat B, Hildebrandt G, Muller AC, Plasswilm L, Papachristofilou A, Schar C, Sumila M, Zaugg K, Guckenberger M, Ost P, Reuter C, Bosetti DG, Khanfir K, Gomez S, Wust P, Thalmann GN, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: The SAKK 09/10 Randomized Phase 3 Trial. Eur Urol. 2021 Sep;80(3):306-315. doi: 10.1016/j.eururo.2021.05.033. Epub 2021 Jun 14.
PubMed 34140144Ghadjar P, Hayoz S, Bernhard J, Zwahlen DR, Holscher T, Gut P, Guckenberger M, Hildebrandt G, Muller AC, Plasswilm L, Papachristofilou A, Stalder L, Biaggi-Rudolf C, Sumila M, Kranzbuhler H, Najafi Y, Ost P, Azinwi NC, Reuter C, Bodis S, Kaouthar K, Wust P, Thalmann GN, Aebersold DM. Acute Toxicity and Quality of Life After Dose-Intensified Salvage Radiation Therapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: First Results of the Randomized Trial SAKK 09/10. J Clin Oncol. 2015 Dec 10;33(35):4158-66. doi: 10.1200/JCO.2015.63.3529. Epub 2015 Nov 2.
PubMed 26527774
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Intensified Salvage Radiotherapy in Biochemically Relapsed Prostate Cancer Without Macroscopic Disease. A Randomized Phase III Trial.
- ClinicalTrials.gov ID
- NCT01272050
- Acronym / sponsor ID
- SAKK 09/10
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- 6 Jan 2011 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Jan 2011 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with relapsed prostate cancer.
PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy and comparing two radiation therapy regimens in treating patients with relapsed prostate cancer after surgery.
Detailed description
OBJECTIVES:
- To determine the tumor control in patients with biochemically relapsed prostate cancer without macroscopic disease treated with dose-intensive salvage radiotherapy.
- To determine the toxicity in these patients.
- To determine the quality of life of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), pathological tumor classification (pT3b vs others), lymphadenectomy performed (yes [pN0] vs no [cN0]), persistent PSA after prostatectomy (detectable [≥ 0.1 ng/mL] vs undetectable [< 0.1 ng/mL]), PSA at randomization (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center, and radiotherapy technique (3-dimensional conformal radiation therapy [3D-CRT] vs intensity-modulated radiation therapy [IMRT]/rotational techniques). Patient are randomized to 1 of 2 treatment arms.
- Arm A: Beginning at least 12 weeks after surgery, patients undergo radiotherapy* once a day, 5 days a week, for 6.4 weeks for a total dose of 64 Gy (in 32 fractions of 2 Gy over 6.4 weeks).
- Arm B: Patients undergo radiotherapy* once a day, 5 days a week, for 7 weeks for a total dose of 70 Gy (in 35 fractions of 2 Gy over 7 weeks).
NOTE: *3-dimensional conformal radiation therapy, rotational techniques such as Tomotherapy®, Rapidarc®, or intensity-modulated arc technique and volumetric-modulated arc therapy are all eligible.
Patients complete quality-of-life questionnaires at baseline and at 3, 12, 24, 36, 48, and 60 months after completing study therapy.
After completion of study treatment, patients are followed every 6 months for 3 years and then every 12 months for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: 64 Gy - Radiation Therapy | Active comparator | Radiation: radiation therapyArm A: 64 Gy (32 x 2 Gy) without hormonal treatment |
| Arm B: 70 Gy - Radiation Therapy | Active comparator | Radiation: radiation therapyArm B: 70 Gy (35 x 2 Gy) without hormonal treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must give written informed consent before randomization.
- Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy at least 12 weeks before randomization. Tumor stage pT2a-3b, R0-1, pN0 or cN0 according to the UICC TNM 2009 (see Appendix 1), Gleason score available.
- PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises. The first value must be measured earliest 4 weeks after radical prostatectomy.
- PSA at randomization ≤ 2 ng/mL.
- WHO performance status 0-1 at randomization.
Key exclusion criteria (12 listed)
- Persistent PSA 4-20 weeks after radical prostatectomy > 0.4 ng/mL
- Palpable prostatic fossa mass suggestive of recurrence, unless an ultrasound guided biopsy is non-malignant.
- Pre-salvage RT pelvic lymph node enlargement > 1 cm in short axis diameter of the abdomen and pelvis (cN1), unless the enlarged lymph node is sampled and negative, and/or evidence of macroscopic local recurrence or metastatic disease on pre-salvage RT MRI (magnetic resonance imaging; with i.v. contrast) or multislice computed tomography (CT; with i.v. and oral contrast) of the abdomen and pelvis assessed within 16 weeks prior to randomization.
- Presence or history of bone metastases. Bone scan must be performed in case of clinical suspicion (e.g. bone pain).
- Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival for a minimum of 5 years.
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 |
|---|---|---|
| radiation therapyRT in the standard arm A will be administered to a total dose of 64 Gy in 32 fractions of 2 Gy over 6.4 weeks. RT in the experimental arm B will be administered to a total dose of 70 Gy in 35 fractions of 2 Gy over 7 weeks. Megavoltage equipments with nominal photon energies ≥ 6 MV are required. Rotational techniques such as Tomotherapy®, Rapidarc®, intensity-modulated arc technique (IMAT) and volumetric-modulated arc therapy (VMAT) will also be eligible. The patient will be treated in an isocentric setting and all fields will be applied for 5 days per week for the total RT duration. | Radiation | Arm A: 64 Gy - Radiation Therapy, Arm B: 70 Gy - Radiation Therapy |
Primary outcome
Freedom from biochemical progression
Time frame: from the day of trial randomization to the day of either first recorded biochemical progression, clinical progression or death due to clinical progression up to 10 years.
5 secondary outcomes
Clinical progression-free survival
Time frame: from the day of randomization to the day of the first record of either local or regional recurrence, distant recurrence, start of hormonal treatment, or death due to any cause up to 10 years.
Time to hormonal treatment
Time frame: time from trial randomization to start of hormonal treatment up to 10 years.
Prostate cancer-specific survival
Time frame: time from trial randomization to the date of death due to prostate cancer up to 10 years.
Overall survival
Time frame: time from trial randomization to the date of death from any cause up to 10 years.
Acute and late gastrointestinal and genitourinary toxicity according to CTCAE v 4.0
Time frame: occurring during treatment and up to 3 months after completion of treatment. Late toxicity is defined as occurring later than 3 months after end of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 41494929Ghadjar P, Hayoz S, Zwahlen DR, Holscher T, Arnold W, Polat B, Hildebrandt G, Hoffmann E, Plasswilm L, Papachristofilou A, Schar C, Sumila M, Zaugg K, Guckenberger M, Ost P, Reuter C, Bosetti DG, Khanfir K, Riesterer O, Beck M, Thalmann GN, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: Long-term Data from the SAKK 09/10 Randomised Phase 3 Trial. Eur Urol. 2026 Mar;89(3):199-203. doi: 10.1016/j.eururo.2025.12.020. Epub 2026 Jan 5.
- Derived from this study: PubMed 38706726Zwahlen DR, Schroder C, Holer L, Bernhard J, Holscher T, Arnold W, Polat B, Hildebrandt G, Muller AC, Martin Putora P, Papachristofilou A, Schar C, Hayoz S, Sumila M, Zaugg K, Guckenberger M, Ost P, Giovanni Bosetti D, Reuter C, Gomez S, Khanfir K, Beck M, Thalmann GN, Aebersold DM, Ghadjar P. Erectile function preservation after salvage radiation therapy for biochemically recurrent prostate cancer after prostatectomy: Five-year results of the SAKK 09/10 randomized phase 3 trial. Clin Transl Radiat Oncol. 2024 Apr 25;47:100786. doi: 10.1016/j.ctro.2024.100786. eCollection 2024 Jul.
- Derived from this study: PubMed 34990777Beck M, Sassowsky M, Schar S, Mathier E, Halter M, Zwahlen DR, Holscher T, Arnold W, Polat B, Hildebrandt G, Muller AC, Putora PM, Papachristofilou A, Hayoz S, Schar C, Li Q, Sumila M, Zaugg K, Guckenberger M, Ost P, Bosetti DG, Reuter C, Gomez S, Khanfir K, Aebersold DM, Ghadjar P, Pra AD. Adherence to Contouring and Treatment Planning Requirements Within a Multicentric Trial: Results of the Quality Assurance of the SAKK 09/10 trial. Int J Radiat Oncol Biol Phys. 2022 May 1;113(1):80-91. doi: 10.1016/j.ijrobp.2021.12.174. Epub 2022 Jan 3.
- Derived from this study: PubMed 34140144Ghadjar P, Hayoz S, Bernhard J, Zwahlen DR, Holscher T, Gut P, Polat B, Hildebrandt G, Muller AC, Plasswilm L, Papachristofilou A, Schar C, Sumila M, Zaugg K, Guckenberger M, Ost P, Reuter C, Bosetti DG, Khanfir K, Gomez S, Wust P, Thalmann GN, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: The SAKK 09/10 Randomized Phase 3 Trial. Eur Urol. 2021 Sep;80(3):306-315. doi: 10.1016/j.eururo.2021.05.033. Epub 2021 Jun 14.
- Derived from this study: PubMed 26527774Ghadjar P, Hayoz S, Bernhard J, Zwahlen DR, Holscher T, Gut P, Guckenberger M, Hildebrandt G, Muller AC, Plasswilm L, Papachristofilou A, Stalder L, Biaggi-Rudolf C, Sumila M, Kranzbuhler H, Najafi Y, Ost P, Azinwi NC, Reuter C, Bodis S, Kaouthar K, Wust P, Thalmann GN, Aebersold DM. Acute Toxicity and Quality of Life After Dose-Intensified Salvage Radiation Therapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: First Results of the Randomized Trial SAKK 09/10. J Clin Oncol. 2015 Dec 10;33(35):4158-66. doi: 10.1200/JCO.2015.63.3529. Epub 2015 Nov 2.
- Individual participant dataSharing planned: No
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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.
Pirus Ghadjar, MD study chair
Charite University, Berlin, Germany
Daniel M. Aebersold, Prof. study chair
Bern University Hospital
George N. Thalmann, Prof. study chair
Bern University Hospital
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation therapy in people with Prostate Cancer, run by Swiss Cancer Institute at 28 sites in 3 countries.
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 10 inclusion and 12 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: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Switzerland, Germany, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from biochemical progression (time frame: from the day of trial randomization to the day of either first recorded biochemical progression, clinical progression or death due to clinical progression up to 10 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 NCT01272050, which also lists 5 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 28 Aug 2024.