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Not yet recruiting NCT07460726

PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer

— Observational Prostate Cancer (Adenocarcinoma) Erectile Abnormalities Sexual Dysfunction Male

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT combined with ADT.
Who it may be relevant to
Registry conditions: Prostate Cancer (Adenocarcinoma), Erectile Abnormalities, Sexual Dysfunction Male. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single Arm Prospective Study to Investigate the Impact of Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) on Sexual Dysfunction in Unfavorable Intermediate Risk Prostate Cancer

Overview

This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.

Detailed description

This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.

Interventions

  • Combination product SBRT combined with ADT
    SBRT combined with Zoladex

Primary outcome measures

  • Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score. [Time frame: Baseline, 3, 9, 15, and 24 months post-SBRT]
Secondary outcome measures (5)
  • Proportion of patients with clinically significant (moderate to severe) erectile dysfunction [Time frame: Baseline, 3, 9, 15, and 24 months]
  • Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score [Time frame: Baseline, 3, 9, 15, and 24 months]
  • Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26) [Time frame: Baseline, 3, 9, 15, and 24 months]
  • Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8) [Time frame: Baseline, 3, 9, 15, and 24 months]
  • Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14 [Time frame: Baseline, 3, 9, 15, and 24 months (for patients >70 years)]

Eligibility criteria

Inclusion criteria

  • Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network \[NCCN\] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c)
  • Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months)
  • Baseline sexual function assessment available (International Index of Erectile Function \[IIEF-5, also known as SHIM\] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Written informed consent to participate.

Exclusion criteria

  • Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
  • Pre-existing severe sexual dysfunction (IIEF-5 score < 12 or pre-selection erection status score of 0: no erection)
  • Hypogonadism at presentation (baseline testosterone below normal range)
  • Contraindications to SBRT or ADT
  • Metastatic disease, second malignancy, or previous malignancies.
  • Benign or malignant penile diseases.
  • Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors)
  • Psychiatric conditions affecting questionnaire completion or QoL assessment
  • Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Manitoba Prostate Centre — Winnipeg

Publications

  • Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361. PMID 17099194
  • Balachandran VP, Gonen M, Smith JJ, DeMatteo RP. Nomograms in oncology: more than meets the eye. Lancet Oncol. 2015 Apr;16(4):e173-80. doi: 10.1016/S1470-2045(14)71116-7. PMID 25846097
  • Kennady EH, Bryk DJ, Ali MM, Ratcliffe SJ, Mallawaarachchi IV, Ostad BJ, Beano HM, Ballantyne CC, Krzastek SC, Clements MB, Gray ML, Rapp DE, Ortiz NM, Smith RP. Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial. Sex Med. 2023 Nov 11;11(5):qfad053. doi: 10.1093/sexmed/qfad053. eCollection 2023 Oct. PMID 37965376
  • Skolarus TA, Dunn RL, Sanda MG, Chang P, Greenfield TK, Litwin MS, Wei JT; PROSTQA Consortium. Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form. Urology. 2015 Jan;85(1):101-5. doi: 10.1016/j.urology.2014.08.044. PMID 25530370
  • Laviana AA, Hernandez A, Huang LC, Zhao Z, Koyama T, Conwill R, Hoffman K, Feurer ID, Goodman M, Hamilton AS, Wu XC, Paddock LE, Stroup A, Cooperberg MR, Hashibe M, O'Neil BB, Kaplan SH, Greenfield S, Penson DF, Barocas DA. Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes? J Urol. 2019 Dec;202(6):1150-1158. doi: 10.1097/JU.0000000000000392. E PMID 31216252
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PMID 18929686
  • Alayed Y, Davidson M, Quon H, Cheung P, Chu W, Chung HT, Vesprini D, Ong A, Chowdhury A, Liu SK, Panjwani D, Helou J, Musunuru HB, Pang G, Korol R, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Commisso A, Commisso K, D'Alimonte L, Ho L, Bhounr Z, Loblaw A. Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy. Radiother Oncol. 2020 Mar;144 PMID 31809979
  • Matsushima M, Kikuchi E, Matsumoto K, Kosaka T, Mizuno R, Ohashi T, Mikami S, Miyajima A, Shigematsu N, Oya M. Erectile function status is highly associated with prostate-specific antigen bounce in localized prostate cancer patients treated with permanent prostate brachytherapy. Int J Urol. 2016 Mar;23(3):247-52. doi: 10.1111/iju.13029. Epub 2015 Dec 12. PMID 26663514

Identifiers

NCT: NCT07460726 · 1219

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗