Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery

NCT01272050 | Completed Phase 3 DMC

• 4 other identifiers: SAKK 09/10SWS-SAKK-09/10EU-21088CDR0000691926
• Study Type: interventional
• Target: 350
• Locations: 3 countries
• Sites: 28

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IIA prostate cancer; stage IIB prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Freedom from biochemical progression

  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

  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 from trial randomization to start of hormonal treatment up to 10 years.

• Prostate cancer-specific survival

  time from trial randomization to the date of death due to prostate cancer up to 10 years.

• Overall survival

  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

  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.

Study Arms (2)

Arm A: 64 Gy - Radiation Therapy

ACTIVE COMPARATOR

Arm A: 64 Gy (32 x 2 Gy) without hormonal treatment

Radiation: radiation therapy

Arm B: 70 Gy - Radiation Therapy

ACTIVE COMPARATOR

Arm B: 70 Gy (35 x 2 Gy) without hormonal treatment

Radiation: radiation therapy

Interventions

radiation therapy RADIATION

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.

Arm A: 64 Gy - Radiation Therapy; Arm B: 70 Gy - Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (28)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

St. Lukas Hospital Ghent

Ghent, 9000, Belgium

Location

Universitaetsklinikum Aachen, Klinik für Strahlentherapie

Aachen, 52074, Germany

Location

Charite University Hospital - Campus Virchow Klinikum

Berlin, 13353, Germany

Location

University Hospital and Medical Faculty Technical University of Dresden

Dresden, D-01307, Germany

Location

Universitaetsklinikum Essen, Klinik für Strahlentherapie

Essen, 45147, Germany

Location

Universitätsklinikum Saarland

Homburg, 66421, Germany

Location

Klinikum der LMU Muenchen

Munich, D-81377, Germany

Location

Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, 93051, Germany

Location

Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock

Rostock, 18059, Germany

Location

Universitaet Tuebingen

Tübingen, 72076, Germany

Location

Klinik fuer Strahlentherapie Universitaet Wuerzburg

Würzburg, 97080, Germany

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Radio-Onkologiezentrum Biel-Seeland-Berner Jura AG

Biel, 2503, Switzerland

Location

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Kantonsspital Muensterlingen

Münsterlingen, 8596, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Hopital de Sion

Sion, 1951, Switzerland

Location

Radio-Onkologie Berner Oberland AG

Thun, 3600, Switzerland

Location

Klinik Hirslanden

Zurich, 8032, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, 8091, Switzerland

Location

Related Publications (5)

• 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 Jan 5:S0302-2838(25)04875-4. doi: 10.1016/j.eururo.2025.12.020. Online ahead of print.

  PMID: 41494929 DERIVED

• Zwahlen 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.

  PMID: 38706726 DERIVED

• Beck 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.

  PMID: 34990777 DERIVED

• Ghadjar 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.

  PMID: 34140144 DERIVED

• Ghadjar 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.

  PMID: 26527774 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pirus Ghadjar, MD

  Charite University, Berlin, Germany

  STUDY CHAIR

• Daniel M. Aebersold, Prof.

  Bern University Hospital

  STUDY CHAIR

• George N. Thalmann, Prof.

  Bern University Hospital

  STUDY CHAIR

• Daniel Zwahlen, PD Dr.

  Kantonsspital Graubünden

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: January 6, 2011
• Primary Completion: July 3, 2020
• Study Completion: May 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); CH (14); BE (3)