PROSPEC study; PROstate cancer follow-up care in Secondary and Primary hEalth Care

Conditions: prostate cancer
prostatic adenocarcinoma
10038597
10018188

Registration Number: NL-OMON48798

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 390

Inclusion Criteria

- Men diagnosed with invasive prostate cancer;
- Stage cT1a - cT3; pNx - pN1; R0-1 having completed primary treatment
(prostatectomy or radiotherapy);
- Radiotherapy with or without androgen deprivation therapy (ADT) for localized
prostate cancer
- No evidence of recurrence (PSA<0.1 ng/ml after prostatectomy or PSA<
nadir+2.0 ng/mL after radiotherapy).

Exclusion Criteria

- Primary treatment (prostatectomy, radiotherapy) completed longer than 6
months previously;
- Patients under active surveillance;
- Under investigation for possible recurrence (patients become eligible if
recurrence is ruled out);
- Does not have a community-based GP to provide care;
- Unable to comply with study protocol including completion of questionnaires;
- Actively followed by a cancer specialist for another primary cancer;
- (Previously) enrolled in a study requiring ongoing follow-up by a cancer
specialist;
- Serious (treatment related) toxicity that requires treatment;
- Patients that cannot sign informed consent or are unable to understand Dutch.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the effect of GP-based versus specialist-based follow-up<br /><br>care on adherence to the prostate cancer surveillance guideline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include the time from a biochemical recurrence (BCR) to<br /><br>prostate cancer retreatment decision-making in an interdisciplinary setting,<br /><br>management of treatment-related side effects and comorbidities, health<br /><br>promotion recommendations, prostate-cancer related anxiety and quality of life,<br /><br>continuity of care, and cost-effectiveness. </p><br>