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NCT Number: NCT06678126

Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)

The study is being done to compare the side effects between two different radiation techniques, standard non-adaptive radiation therapy vs. daily adaptive radiation therapy and also comparing two different bladder filling instructions to find out if customized bladder instructions may lead to better treatment outcomes.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

BC Cancer Vancouver

Vancouver, British Columbia, V5Z4E6, Canada

Location contact

Sandy Chang

CONTACT

[email protected]

6046754100 ext. 202199

Scott Tyldesley, MD FRCPC

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Pathological diagnosis of a primary prostate adenocarcinoma
  • NCCN Intermediate or high risk localized prostate cancer and clinically N0 and M0 by conventional imaging
  • Intermediate: one or more of cT2b-T2c, PSA 10-20, or Gleason Group 2 or 3
  • High: one or more of: cT3a, PSA > 20, or Gleason Group 4 or 5.
  • Consented to RT with moderate hypofractionated RT to pelvic nodes (44 Gy) and prostate (60Gy) in 20 fractions using standard BC Cancer regimen
  • Able to complete BC Cancer POSI questionnairesWilling to attend adaptive treatment slot timing as required by treating centre.
  • Willing and able to have regular per protocol follow up and blood work
  • Feasible to start protocol treatment within 120 calendar days of participant enrolment
  • Continent of urine (or able to maintain continence with penile clamp/cuff during RT as needed) and able to follow bladder filling instructions.
  • Baseline IPSS score < 20 at time of enrolment.
  • ECOG performance Status : 0-2.
  • Nodal risk ≥ 20% using the Memorial Sloan Kettering Nodal Risk Nomogram (https://www.mskcc.org/nomograms/prostate/pre_op).
  • Negative for bone metastases on bone scan within 3 months of enrolment
  • No involved nodes on Abdomen and pelvic CT or pelvic MRI within 3 months of enrolment.

Exclusion criteria

  • Indwelling urinary catheter.
  • Hip prosthesis
  • Prior pelvic radiotherapy
  • Unable to lie still on RT treatment couch for more than 30 minutes
  • Clinical T3b or T4 tumours
  • Prior transurethral resection of prostate or radical prostatectomy
  • Presence of a pelvic kidney.
  • Prior pelvic radiotherapy.
  • Significant urinary incontinence: ie > 1 soaked, or 2 non-soaked pads per day.
  • Inflammatory bowel disease, systemic lupus erythematosis, scleroderma, or other connective tissue disorders other than rheumatoid arthritis.
  • Metastatic disease identified on staging investigations.
  • Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines
  • Potentially fertile patient who are unwilling to employ highly effective contraception

Treatment and study plan

Prostate and Pelvic Nodes Radiotherapy

Radiation

60 Gy prostate and 44 Gy pelvic nodes with 20 fractions

Primary outcomes

  1. Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.

    Time frame: Accrual period, estimated 3.5 years

    Accrual and randomization rate will be captured in REDCap database until the goal of 104 participants are randomized. With the accrual rate, we may imply it is feasible to do a larger more definitive and timely randomized control trial.

Secondary outcomes

  1. Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.

    Time frame: 5 years after participant completes RT

    using Patient reported questionnaire (POSI) to review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT.

  2. Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.

    Time frame: 5 years after participant completes RT

    using Patient reported questionnaire (POSI) to review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT.

  3. Measure and compare the physician reported CTCAE Acute (6 weeks post RT) GU and GI bladder CTCAE toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer

    Time frame: 5 years after participant completes RT

    review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT.

  4. Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time

    Time frame: approx 4 weeks during treatment of 20 fractions

    using treatment time record during the 20 fractions

  5. Determine which BFIs are associated with least rescan and repeat CBCT requirements

    Time frame: approx 4 weeks during treatment of 20 fractions

    using records from treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sandy Chang

CONTACT

[email protected]

604-675-4100 ext. 202199

Sponsors and collaborators

Lead sponsor

Scott Tyldesley

Other

Registry information

Official study title

Randomized Phase II 2 by 2 Factorial Trial of Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)

Important dates

Study start
2025
Primary completion
2033
Study completion
2035
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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