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Prostate CancerPCS-XINCT05820633

Pelvic Nodes Ultra-Hypo vs Conventionally Fractionated IMRT With HDR Boost in Prostate Cancer.

A study testing Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS), Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26): and Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM) in people with Prostate Cancer and Node; Prostate, run by CHU de Quebec-Universite Laval at 11 sites in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Read more about this study

Who is it for?
Ages 18 to 95 years, men only
What is being tested?
Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS), Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26): and Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
11 sitesCanada
Study dates
1 Sep 2022to Dec 2035
Phase
Interventional
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 95 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed adenocarcinoma of the prostate.
  • All clinical stages with lymph node involvement risk needing pelvis RT.
  • Stage Mx or M0.
  • Unfavorable Intermediate, high or very high-risk disease according to NCCN guidelines.
  • Having the ability to give free and informed consent.

Who cannot join

  • Clinical stage M1.
  • IPSS Score > 20 with alpha-blocking medication.
  • Prior pelvic radiotherapy,
  • History of active collagenosis (Lupus, Scleroderma, Dermatomyositis).
  • Past history of Inflammatory Bowell Disease.
  • Bilateral hip prosthesis.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • CISSS de l'Outaouais, Hôpital de Gatineau

    Gatineau, Quebec, J8P 7H2

  • BC Cancer Sindi Ahluwalia centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • CISSS de Laval, Hôpital de la Cité-de-la-Santé

    Laval, Quebec, H7M 3L9

  • CISSS de la Montérégie-Centre, Hôpital Charles-Le Moyne

    Longueuil, Quebec, J4V 2H1

  • Carlo Fidani Peel Regional Cancer Centre

    Mississauga, Ontario, L5M 2N1

  • CIUSSS du Centre-Ouest-de-l'Île-de-Montréal, Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Cedars Cancer Centre, McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • CIUSSS de l'Est-de-l'Île-de-Montréal, Hôpital Maisonneuve-Rosemont

    Montreal East, Quebec, H1T 2M4

  • Lakeridge Health Oshawa Cancer centre

    Oshawa, Ontario, L1G 2B9

  • CHU de Québec - Université Laval

    Québec, G1R 2J6

  • CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec

Other trials in Canada

About this study

Official title: Pelvic Nodes Ultra-Hypo Fractionated Versus Conventionally Fractionated IMRT With HDR Brachytherapy Boost in Prostate Cancer: A Collaborative Multi-institutional Non-inferiority Phase 3 Trial. (PCS-XI)

Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.

Read the detailed description

Prostate cancer is the most common non-skin cancer in North American men. In 2020, an estimated 23 300 Canadian men will be diagnosed with prostate cancer of which, 4200 will die. Fortunately, with an early screening, most will have a localized disease at diagnosis. Despite this, high risk disease affects a growing portion of the population and this according to age (29.3%, 39.1%, 60.4%, et 90.6% respectively at 55-59, 65-69, 75-79, \& 85-89 years of age). Gleason score 8 to 10 tumors follow the same pattern (16.5%, 23.4%, 37.2%, and 59.9% at respective ages). Those patients are at risk for harboring lymph nodes metastasis.

Multiple therapeutic options, with similar biochemical disease-free survival (bDFS) are available: surgery +/- salvage radiotherapy +/- androgen deprivation therapy (ADT) or radiotherapy (RT) +/- HDR-BT +/- ADT. For men with high-risk disease, the combined approach of RT + HDR-BT + ADT might even offer higher cancer specific survival (CSS) rates when compared to surgery.

HDR-BT allows for the delivery of a very high (ablative) dose of radiation while giving a lower dose to the nearby organs at risk (OARs). Recently published literature showed that pelvic RT plus HDR-BT significantly increased bDFS (84 vs 77%).

Pelvic RT is generally given on a daily basis (5 days/week) over a period of 4-5 weeks, with 1,8-2,15Gy per fraction. This requires a substantial time investment from patients undergoing treatment. Many studies have shown that prostate cancer offers a radiation cell kill ratio (α/β) of 0.9-1.5 Gy. Furthermore, the most commonly used α/β value for prostate cancer is 1,5 Gy (range 0,8 - 2,2). This low α/β ratio offers a more efficient cell kill with hypo-fractionated doses, offering a better tumor control with a lower cumulative dose, given in a shorter time span. Recently, a multicentric randomized phase III study has shown similar late toxicity and oncologic control outcomes between UHF (>/= 5 Gy/fraction) and conventionally fractionated RT. However, until now, no phase III study has compared combined UHF pelvic RT to standard fractionation combined with an HDR-BT in this population.

The proposed experimental fractionation scheme for whole pelvic RT in this study will be 5Gy administered every other day over 2 weeks (UHF). It will be compared to standard pelvic RT (1.8-2.15Gy/working day) given over 4 to 5 weeks. Both will be combined with a single 15 Gy fraction of HDR-BT and ADT (goserelin). The UHF treatment modality significantly reduces the overall treatment time, freeing machine-time and allowing more patients to be treated. Given its low α/β ratio, prostate cancer is readily amenable to UHF fractionation. The bio-equivalent dose calculations were done based on published litterature. Neo-adjuvant and adjuvant ADT (goserelin) will be administered for a duration according to NCCN guidelines.

In these COVID-19 pandemic times, a reduction in the number of patients' visits to the clinic is highly desirable in order to limit the risk of virus transmission. UHF would also lower the socio-economic burden incurred by the patients and their families. It also increases the therapeutic efficiency reducing costs for both, patients and health services. The proposed study aims to demonstrate the non-inferiority of UHF treatment compared to standard of care. If this hypothesis is confirmed, all future patients could benefit from it.

In order to improve the quality of life of men diagnosed with prostate cancer this study aim to demonstrate that combined UHF pelvic RT plus HDR-BT (+ ADT according to NCCN guidelines) is safe and non-inferior to standard fractionation regimens in regard to toxicities and tumor control for prostate cancer patients with risk of nodal involvement. Therefore, 500 men will be recruited, in order to confirm the hypothesis.

Being tested
Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS), Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):, Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM), Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE), Report and compare the biochemical disease free survival (bDFS)
Keywords
ultra hypo fractionation, brachytherapy
Medical subject headings
Prostatic Neoplasms, Radiation Injuries

What participants receive

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

  • Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS)Radiation

    Assess early and late genito-urinary (GU) toxicities induced assessed via the International Prostate Symptom Score (I-PSS) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

  • Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):Radiation

    Assess early and late genito-urinary (GU) and gastro-intestinal (GI) toxicities induced and quality of life assessed via expanded prostate cancer index composite (EPIC-26) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

  • Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM)Radiation

    Assess early and late sexual health in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

  • Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE)Radiation

    Assess early and late toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UHF group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

  • Report and compare the biochemical disease free survival (bDFS)Radiation

    Assess the 5 and 10 years biochemical disease-free survival (bDFS) in the UHF group and compare them for non-inferiority to those of the control group.

  • Report and compare the disease free survival (DFS)Radiation

    Assess the 5 and 10 years disease-free survival (DFS) in the UHF group and compare them for non-inferiority to those of the control group.

  • Report and compare the metastase free survival (MFS)Radiation

    Assess the 5 and 10 years metastasis-free survival (MFS) in the UHF group and compare them for non-inferiority to those of the control group.

  • Report and compare the overall survival (OS)Radiation

    Assess the 5 and 10 years overall survival (OS) in the UHF group and compare them for non-inferiority to those of the control group.

Study groups in NCT05820633
Study groupRoleWhat they receive
ultra hypo fractionation radiation therapy (UHF)Experimental5 radiation treatments (5 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given every other day over 2 weeks for a total of 25 Gy.
Receives: Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS); Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):; Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM); Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE); Radiation: Report and compare the biochemical disease free survival (bDFS); Radiation: Report and compare the disease free survival (DFS); Radiation: Report and compare the metastase free survival (MFS); Radiation: Report and compare the overall survival (OS)
standard of care fractionation (SOC)Active comparator20-25 radiation treatments (range: 1,8 to 2,15 Gy per fraction) to the prostate, seminal vesicle and pelvic nodes given in 20-25 working day treatments over 4-5 weeks for a total of 43 Gy to 46 Gy.
Receives: Radiation: Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS); Radiation: Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26):; Radiation: Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM); Radiation: Report and compare changes in a non-inferiority analysis of the toxicities reported according to the Common Terminology Criteria for Adverse Events (CTCAE); Radiation: Report and compare the biochemical disease free survival (bDFS); Radiation: Report and compare the disease free survival (DFS); Radiation: Report and compare the metastase free survival (MFS); Radiation: Report and compare the overall survival (OS)

What is being measured

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

  1. Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced.

    Assess early genito-urinary (GU) toxicities induced opposed to baseline assessed via the International Prostate Symptom Score (I-PSS) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

    Measured: Every 3 months for 1 year.

  2. Non-inferiority analysis of early change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.

    Assess early health-related quality of life opposed to baseline assessed via the Expanded Prostate Cancer Index Composite (EPIC-26) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year.

    Measured: Every 3 months for 1 year.

  3. Non-inferiority analysis of late change in genito-urinary (GU) toxicities induced.

    Assess late genito-urinary (GU) toxicities induced opposed to baseline evaluated by the International Prostate Symptom Score (I-PSS) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group).

    Measured: Every 6 months up to 36 months, then annually up to 10 years.

  4. Non-inferiority analysis of late change in reported Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire.

    Assess late health-related quality of life opposed to baseline assessed via the Expanded Prostate Cancer Index Composite (EPIC-26) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 6 months up to 36 months, then annually.

    Measured: Every 6 months up to 36 months, then annually up to 10 years.

  5. Non-inferiority analysis of early change in sexual health.

    Assess early quality of life opposed to baseline assessed via the Sexual Health Inventory for Men (SHIM) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year.

    Measured: Every 3 months for 1 year.

  6. Non-inferiority analysis of late change in sexual health.

    Assess early sexual health status opposed to baseline assessed via the Sexual Health Inventory for Men (SHIM) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 6 months up to 36 months, then annually.

    Measured: Every 6 months up to 36 months, then annually up to 10 years.

  7. Non-inferiority analysis of early change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).

    Assess early reported toxicities opposed to baseline assessed via the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year, every 6 months up to 36 months, then annually.

    Measured: Every 3 months for 1 year.

  8. Non-inferiority analysis of late change in toxicities reporte via the Common Terminology Criteria for Adverse Events (CTCAE).

    Assess early reported toxicities opposed to baseline assessed via the Common Terminology Criteria for Adverse Events (CTCAE) in the experimental UH group has compared in a non-inferiority analysis to those of patients who received a standard treatment (control group) every 3 months for 1 year, every 6 months up to 36 months, then annually.

    Measured: Every 6 months up to 36 months, then annually up to 10 years.

Secondary outcomes (8)

  1. Non-inferiority analysis of 5 years biochemical Disease Free Survival.

    Assess the 5 years the biochemical disease-free survival (bDFS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 5 years (median)

  2. Non-inferiority analysis of 5 years Disease Free Survival.

    Assess the 5 years the disease-free survival (DFS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 5 years (median)

  3. Non-inferiority analysis of 5 years Metastasis Free Survival.

    Assess the 5 years the Metastasis Free Survival (MFS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 5 years (median)

  4. Non-inferiority analysis of 5 years Overall Survival.

    Assess the 5 years the Overall Survival (OS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 5 years (median)

  5. Non-inferiority analysis of 10 years biochemical Disease Free Survival.

    Assess the 10 years the biochemical disease-free survival (bDFS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 10 years (median)

  6. Non-inferiority analysis of 10 years Disease Free Survival.

    Assess the 10 years the disease-free survival (DFS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 10 years (median)

  7. Non-inferiority analysis of 10 years Metastasis Free Survival.

    Assess the 10 years the Metastasis Free Survival (MFS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 10 years (median)

  8. Non-inferiority analysis of 10 years Overall Survival.

    Assess the 10 years the Overall Survival (OS) in the UH group and compare them for non-inferiority to those of the control group.

    Measured: 10 years (median)

Timeline

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

  1. First posted19 Apr 2023
  2. Study start1 Sep 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2035 (estimated)

Why it stopped: amendment to be done, adding 200 patients

Resources

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
Model description
randomized phase 3 study
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820633
Sponsor's protocol ID
MP-20-2023-6396: PCS XI
Acronym
PCS-XI
Status last verified
Sep 2025
First submitted
26 Feb 2023
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huynh-Le MP, Myklebust TA, Feng CH, Karunamuni R, Johannesen TB, Dale AM, Andreassen OA, Seibert TM. Age dependence of modern clinical risk groups for localized prostate cancer-A population-based study. Cancer. 2020 Apr 15;126(8):1691-1699. doi: 10.1002/cncr.32702. Epub 2020 Jan 3.

    PubMed 31899813

  • Heidenreich A, Varga Z, Von Knobloch R. Extended pelvic lymphadenectomy in patients undergoing radical prostatectomy: high incidence of lymph node metastasis. J Urol. 2002 Apr;167(4):1681-6.

    PubMed 11912387

  • Greenberger BA, Zaorsky NG, Den RB. Comparison of Radical Prostatectomy Versus Radiation and Androgen Deprivation Therapy Strategies as Primary Treatment for High-risk Localized Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol Focus. 2020 Mar 15;6(2):404-418. doi: 10.1016/j.euf.2019.11.007. Epub 2019 Dec 5.

    PubMed 31813810

  • Yin M, Zhao J, Monk P, Martin D, Folefac E, Joshi M, Jin N, Mortazavi A, Verschraegen C, Clinton S. Comparative effectiveness of surgery versus external beam radiation with/without brachytherapy in high-risk localized prostate cancer. Cancer Med. 2020 Jan;9(1):27-34. doi: 10.1002/cam4.2605. Epub 2019 Nov 7.

    PubMed 31697452

  • Tharmalingam H, Tsang Y, Choudhury A, Alonzi R, Wylie J, Ahmed I, Henry A, Heath C, Hoskin PJ. External Beam Radiation Therapy (EBRT) and High-Dose-Rate (HDR) Brachytherapy for Intermediate and High-Risk Prostate Cancer: The Impact of EBRT Volume. Int J Radiat Oncol Biol Phys. 2020 Mar 1;106(3):525-533. doi: 10.1016/j.ijrobp.2019.09.044. Epub 2019 Oct 11.

    PubMed 31610249

  • Morton G, Loblaw A, Cheung P, Szumacher E, Chahal M, Danjoux C, Chung HT, Deabreu A, Mamedov A, Zhang L, Sankreacha R, Vigneault E, Springer C. Is single fraction 15 Gy the preferred high dose-rate brachytherapy boost dose for prostate cancer? Radiother Oncol. 2011 Sep;100(3):463-7. doi: 10.1016/j.radonc.2011.08.022. Epub 2011 Sep 14.

    PubMed 21924511

  • Hill RP, Rodemann HP, Hendry JH, Roberts SA, Anscher MS. Normal tissue radiobiology: from the laboratory to the clinic. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):353-65. doi: 10.1016/s0360-3016(00)01484-x.

    PubMed 11173128

  • Williams MV, Denekamp J, Fowler JF. A review of alpha/beta ratios for experimental tumors: implications for clinical studies of altered fractionation. Int J Radiat Oncol Biol Phys. 1985 Jan;11(1):87-96. doi: 10.1016/0360-3016(85)90366-9.

    PubMed 3881377

  • McCammon R, Rusthoven KE, Kavanagh B, Newell S, Newman F, Raben D. Toxicity assessment of pelvic intensity-modulated radiotherapy with hypofractionated simultaneous integrated boost to prostate for intermediate- and high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):413-20. doi: 10.1016/j.ijrobp.2008.10.050. Epub 2009 Apr 11.

    PubMed 19362783

  • Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.

    PubMed 31227373

  • Arcangeli G, Saracino B, Gomellini S, Petrongari MG, Arcangeli S, Sentinelli S, Marzi S, Landoni V, Fowler J, Strigari L. A prospective phase III randomized trial of hypofractionation versus conventional fractionation in patients with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):11-8. doi: 10.1016/j.ijrobp.2009.07.1691. Epub 2010 Jan 4.

    PubMed 20047800

  • D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289.

    PubMed 18212313

  • Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8.

    PubMed 11744442

  • Hall WA, Paulson E, Davis BJ, Spratt DE, Morgan TM, Dearnaley D, Tree AC, Efstathiou JA, Harisinghani M, Jani AB, Buyyounouski MK, Pisansky TM, Tran PT, Karnes RJ, Chen RC, Cury FL, Michalski JM, Rosenthal SA, Koontz BF, Wong AC, Nguyen PL, Hope TA, Feng F, Sandler HM, Lawton CAF. NRG Oncology Updated International Consensus Atlas on Pelvic Lymph Node Volumes for Intact and Postoperative Prostate Cancer. Int J Radiat Oncol Biol Phys. 2021 Jan 1;109(1):174-185. doi: 10.1016/j.ijrobp.2020.08.034. Epub 2020 Aug 27.

    PubMed 32861817

  • Gregoire JP, Moisan J, Labrecque M, Cusan L, Diamond P. [Validation of a French adaptation of the international prostatic symptom score]. Prog Urol. 1996 Apr;6(2):240-9. French.

    PubMed 8777417

Questions about this trial

What is this clinical trial studying?

A study testing Report and compare changes in a non-inferiority analysis of the International Prostate Symptom Score (I-PSS), Report and compare changes in a non-inferiority analysis of the expanded prostate cancer index composite" (EPIC-26): and Report and compare changes in a non-inferiority analysis of the Sexual Health Inventory for Men (SHIM) in people with Prostate Cancer and Node; Prostate, run by CHU de Quebec-Universite Laval at 11 sites in Canada.

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 5 inclusion and 6 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: paused, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. 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?

Results are not available in the source record.

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?

Non-inferiority analysis of early change in genito-urinary (GU) toxicities induced. (time frame: Every 3 months for 1 year.). The study lists 8 primary outcomes in all. 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 NCT05820633, which also lists 15 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 12 Sep 2025.

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